Recalling Firm
Stryker Instruments Div. of Stryker Corporation
Stryker Medical Division of Stryker Corporation

Initial Firm Notification of Consignee or Public
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Distribution Pattern
Worldwide Distribution - US Distribution to the states of : KS, MS, WI, NJ, KS, IN, LA, FL and WA., and to the countries of : Canada, Australia, Singapore, Netherlands, UK, Austria, Germany, Switzerland and Czech Republic.
US Distribution to the states of : MI, CA, CT, IL, IN, NY, NC, OH and OK.
Product was distributed to wholesalers for retail sale: AL, CO, GA, KS, MO, MS, NY, OK, LA, PA, TX, WI. There was no foreign/government/military distribution.
Distributed in MA and the following countries: Denmark, Germany, Japan, and The Netherlands.
Internationally to the country of : India
Worldwide distributed - US Nationwide in AZ, CA, CO, CT, FL, GA, IA, IL, IN, MA, MN, MO, NC, NJ, NV, NY, OH, PA, TN, TX, WA, and WI, and internationally in Canada, Netherlands, and South Korea.
Worldwide Distribution - Nationwide Distribution and to the countries of: Turkey, Great Britain, Belgium, Kuwait, Poland, Italy, India, China, Costa Rica, Australia, Malaysia, Jordan and Egypt.
Worldwide Distributed - US Nationwide in the states of: AK,AL,AR,AZ,CA,CO,CT,DC,DE,FL,GA,HI,IA,ID,IL,IN, KS,KY,LA,MA,MD, ME, MI, MN, MO, MS, MT, NC,ND,NE, N H, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and countries of: AUSTRALI A,BAHAMAS,BRAZIL,CANADA, COLOMBIA, COSTA RICA, DENMARK, ENGLAND, GREECE, GUAM, ISRAEL, LITHUANIA, MALAYSIA, NETHERLANDS, NEW ZEALAND, PANAMA, POLAND, PORTUGAL, PUERTO RICO, ROMANIA, and SWEDEN
Nationwide Foreign: Australia Bangladesh Chile Colombia France Germany Hong Kong India Ireland Japan Latvia Mexico Spain Switzerland Thailand Uruguay
AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and Puerto Rico Australia, Austria, Bolivia, Canada, Estonia, Germany, Guam, India, Ireland, Israel, Portugal, South Africa, Switzerland, Uruguay and (Japan - DOD)
US (nationwide) Distribution to the states of : CA, CT, GA, IL, IN, MA, MD, NC, OH, PA, TN, and TX.
USA (nationwide) Distribution and Internationally to Colombia.
The product is sold only in 7-11 stores in Colorado.
US and worldwide: Austria Belgium Croatia Czech Republic Denmark Finland France Germany Great Britain Iceland Ireland Israel Italy Latvia Lebanon Lithuania Netherlands Norway Portugal Spain Sweden Switzerland Tunisia Turkey Russian Fed Guadeloupe Sri Lanka Australia China Hong Kong Indonesia Malaysia Singapore South Korea Taiwan Thailand Japan Chile Colombia Costa Rica Ecuador
US Distribution to the state of : OK and to the countries of : Italy, Germany, France , Belgium, Spain and Japan.
Distribution in the United States and Canada
Nationwide, Canada, and Japan. No govt/VA/military consignees.
AL, AR, AZ, CA, CO, FL, GA, IL, LA, MA, MO, MS, NC, NJ, NY, OH,OK, PA, SC, TX and VA
Nationwide throughout the US and Puerto Rico
No US distribution. JAPAN NETHERLANDS SINGAPORE SWITZERLAND

Product Description
NDI P7 Position Sensor, Stereotaxic Instrument
Macaroni & Cheese microwaveable cups sold under the following brands: 1. Big Win Original Macaroni & Cheese Dinner, UPC 11822-58403. 2. Cheese Club express mac Macaroni Cheese Dinner, UPC 41498-17167, 3. Great Value Macaroni & Cheese Dinner, UPC 78742-08249.
MEDHOT MTI 2000 THERMAL IMAGING SYSTEM - TotalVision software with Elevated Body Temperature Screening module, for use as a medical diagnostic purposes as part of a telethermographic system utilizing FLIR cameras, Models A615sc and A315sc. Cameras are private labeled as MAX Basic, MAX 76 and MAX 307.
Apheresis Red Blood Cells, Leukocytes Reduced
Blood and Blood Products for Reprocessing
Olanzapine Tablets, 20 mg, packaged in a) 30-count bottles (NDC 62756-556-83), b) 100-count bottles (NDC 62756-556-88), and c) 1000-count bottles (NDC 62756-556-18), Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389, 350 Gujarat, India.
Olanzapine Tablets, 2.5 mg, 1000-count bottles, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-551-18.
Olanzapine Tablets, 10 mg, packaged in a) 30-count bottles (NDC 62756-554-83), b) 100-count bottles (NDC 62756-554-88), and c) 1000-count bottles (NDC 62756-554-18), Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389, 350 Gujarat, India, NDC 62756-551-18.
Olanzapine Tablets, 7.5 mg, packaged in a) 30-count bottles (NDC 62756-553-83), b) 100-count bottles (NDC 62756-553-88), and c) 1000-count bottles (NDC 62756-553-18), Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389, 350 Gujarat, India.
Sample probes associated with: cobas 6000 Series System, cobas 8000 Modular Analyzer Series, cobas c 311 analyzer cobas c 501/502 cobas c 701/702 cobas 8000 ISE Product Usage: The cobas 6000 series is a fully automated, random-access, software-controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. It is optimized for high throughput workloads in the professional environment using a combination of Ion selective electrodes (ISE), a photometric analysis unit an immunoassay analysis module. The cobas 8000 Modular Analyzer Series is a fully automated system for Clinical chemistry analysis, intended for the in vitro qualitative and quantitative determination of analytes in body fluids. It is optimized for high throughput workloads in the professional environment using a combination of ion selective electrodes (ISE) and a photometric analysis unit. The cobas c 311 analyzer is an in-vitro diagnostic analyzer capable of performing clinical chemistry, specific protein and electrolyte tests. Analytes are measured photometrically or turbidimetrically; the analyzer also has an optional ISE module for measuring sodium, potassium and chloride.
Mentor Smooth Round SPECTRUM Post- Operatively Adjustable Saline Breast Implant, Product Code: 350-1490, UDI/GTIN: 00081317002048
PrednisoLONE Oral Solution USP, 15 mg/5mL, alcohol content: 5%(v/v) 240 mL bottle, Rx Only, Manufactured in Canada By: CONTRACT PHARMACEUTICALS LIMITED CANADA, Ontario, Canada, L5N 6L6, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-6118-87
Mozobil (plerixafor injection) 24mg/1.2mL (20mg/mL), For Single Use Only, Rx Only, Manufactured by: Genzyme Corporation 500 Kendall Street, Cambridge, MA 02412 USA NDC: 0024-5862-01
Reser's Fine Foods, American Classics Macaroni Salad, Net Wt 1 lb. (454 g) UPC 7117.19007, packaged in 16 oz plastic tubs, 12 per case. Reser's Fine Foods, Inc. Beaverton, OR 97006.
on the case and has a poly liner. This product was to be reprocessed and there are no UPC codes. Grades PBO A, PBO X, PBO XL, PBO L, and MN PBO A.
on the case and has a poly liner. This product was to be reprocessed and there are no UPC codes. Grades Mince A and MN Mince A
Great Value Bread and Butter Chips 24 Fl Oz. Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716 UPC 078742145990
PERI-LOC VOLAR DISTAL RADIUS - RIGHT 3H STD HEAD LOCKING PLATE, 62 MM LENGTH, SST PLATE, REF 71823114, QTY: (1) NON-STERILE, Rx only, Smith & nephew, Inc., Memphis TN 38116
Microfil Composite Instruments are packaged in an unsealed plastic sleeve, which is then placed in a cardboard box. Microfil Composite Instruments are intended to be sterilized by the dentist prior to each use. It is used for composite restoration development. The thin paddles shape light-cured composites. Paddles slide under the gum line to shape the margin. The flat ends contour the surfaces of the teeth and the thin edge is used to create esthetic highlights. Models: #96041 Gold Microfil #96042 Green Microfil #96043 Blue Microfil #96044 Set of 3 Microfil (Gold, Green, Blue)
Mederi Stretta Catheter and Accessory Kit, Sterile For Use with the MEDERI MDRF1 GENERATOR ONLY. Used in the treatment of gastroesophageal reflux disease (GERD). REF 175-5580
CooperSurgical lnflatoball Latex Rubber Pessary sold as an individual unit and also part of the lnflatoball Pessary Kit. Product Usage: The lnflatoball Pessary is a single-patient use pessary manufactured from natural latex rubber and is used for treating cystocele and/or rectocele associated with procidentia or prolapse. The inflatoball Pessary contains one (1) Pessary in a double-pocketed sealed clear plastic pouch, one pocket containing the Pessary and one pocket containing the Instructions for Use (IFU).
Fresh Mozzarella; No brand name. Shipped in 30 lb. plastic bucket
Anthrex SpeedBridge Implant System with PEEK SwiveLock Self Punching
Anthrex Bio Composite SwiveLock SP Vented, 4.75 mm x 24.5 mm, Self-Punching
Anthrex PEEK SwiveLock SP Vented, 5.5mm x 24.5 mm, Self-Punching
Anthrex SpeedBridge Implant System with BioComposite SwiveLock SP Vented, 5.5 mm x 24 mm
Anthrex Bio-SwiveLock SP Vented, 5.5mm x 24.5 mm, Self-Punching
Anthrex PEEK SwiveLock SP Vented, 4.75 mm x 24.5 mm, Self-Punching
Stryker PROFESS Registration Kit. The Stryker PROFESS Registration Kit is a member of the Navigation portfolio and is used as an intraoperative guidance system to enable intranasal and sinus computer-assisted surgery. The system is comprised of PROFESS Registration Stickers, a PROFESS Patient Tracker, and a PROFESS Adaptor Cable.
7-ELEVEN CAESAR SIDE SALAD 3 oz. packaged in clear plastic container
The Bakery Peanut Butter Chocolate Chunk Cookies, Net Wt. 14 oz. (396g), packaged in a clear plastic clam shell, UPC 0 78742 06652 3, Distributed by: Wal-Mart Stores, Inc. Bentonville, AR 72716
Medtronic PAK NEEDLE BEVELED AND TROCAR TIPS, REF 8670009, QTY 1 EA, STERILE R, Rx only
Stromaderm Age-Defying Serum, 1 fluid ounce jar, item number: 400600. Packaged in Glass jar with glass dropper in a unit carton. Sold as individual units, Distributed by: Jusuru International, Inc., Anaheim, CA
Vertical Pharmaceuticals OB Complete with DHA Prenatal Multivitamin, 60 softgels Rx Only, Manufactured for: Vertical Pharmaceuticals, LLC Sayreville, NJ 08872 UPC 368025049603
IC-Green (indocyanine green for injection, USP), 25 mg, packaged in a kit containing six vials of 25 mg lyophilized powder, Rx only, Manufactured by: Akorn, Inc., NDC 17478-701-02
12 count Lays Kettle Cooked Multipack Sack 10.2 oz packaged in flexible plastic
20 count Frito-Lay Bold Mix Sack 18.4 oz. packaged in flexible plastic
32 count Miss Vickies Multipack Box 44 oz. packaged in flexible plastic
30 count Miss Vickies Multipack Tray 41.25 oz. packaged in flexible plastic
30 count Lays Kettle Cooked Multipack Tray 41.25 oz. packaged in flexible plastic
Soylent 1.8 Powder , 7 x 15oz pouches, SKU: 1WK-V108
Regenerex Patella RGX 3 PEG SER A PATELLA 28MM RGX 3 PEG SER A PATELLA 31MM RGX 3 PEG SER A PATELLA 34MM RGX 3 PEG SER A PATELLA 37MM Product Usage: The Regenerex Series A Patella can be used for any non-cemented resurfaced 3-peg patella application within the Vanguard Complete Knee System. 1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. 2. Correction of varus, valgus, or posttraumatic deformity. 3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
Clozapine Tablets USP, 25 mg, 100-count bottle (NDC 0093-4359-01), 500- count bottle (NDC 0093-4359-05), 100 Unit Dose Blisters per carton (NDC 0093-4359-93), Individual Blister Pack (NDC 0093-4359-19), Rx Only, Manufactured By: Teva Pharmaceutical Industries Ltd., Jerusalem, 9777600, Israel
Cobalt HV Bone Cement Cobalt MV Bone Cement Cobalt HV Bone Cement With Gentamicin
Linear Broach Handle Greatbatch Part # T11824, DJO Surgical Inc. # 803-03-059).
Buprenorphine HCI Injection, 0.3 mg/mL, 1 mL Single Dose Vial (NDC 42023-179-01), packaged in 1 mL x 5 Single Dose Vials per carton (NDC 42023-179-05), Rx Only, Distributed by: Par Pharmaceuticals Companies, Inc., Spring Valley, NY 10977.
Red Blood Cells, Leukocytes Reduced, Irradiated

Product Quantity
1773 devices (US =1570; International = 203)

Reason for Recall
Zimmer CAS voluntarily conducted a retrospective recall on specific P7 Position Sensors (Cameras), installed on Sesamoid and Sesamoid Plasty CAS workstations due to a series of these components determined to be affected with a manufacturing issue whereby they may potentially stop functioning during usage.
Products containing cheddar cheese seasoning which may be contaminated with Salmonella.
Indications for use are not cleared or approved for market in the U.S.
Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
Blood product, collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
Blood product, collected from a donor who traveled to a malarial endemic area, was distributed.
Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).
Due to a design change in 2015, corrosion on the sample probe electrical contacts can occur and lead to a disturbance of the sample liquid level detection (LLD). When disturbance of the sample liquid level detection (LLD) occurs, the affected sample probe may dip into the sample material deeper than intended. This may lead to carryover and medical risk cannot be excluded.
During an internal investigation the firm discovered that an ingredient used in various spices may contain Salmonella.
Labeling: Incorrect or Missing Package Insert
Product contains undeclared milk and soy.
Frozen Pollock fillet block is recalled because one customer has found metal fragments in fillet block.
Frozen Pollock mince block is recalled because one customer has found metal fragments in fillet block.
Blood product, prepared without the appropriate amount of additive, was distributed.
Blood product, which did not meet the acceptable product specifications, was distributed.
Glass fragments were found in Great Value Bread and Butter Chips.
This lot of left plates were laser etched and packaged as right plates.
Microfil Composite Instruments were distributed with a sterile symbol on their packaging label inserts, indicating that the products are sold as sterile devices. These products are not sterile and they are intended to be sterile prior to each use.
Product sterility compromised due to breach in sterile barrier package
The current secondary packaging, a box, incorrectly states that the product is latex free. The product is made with 100% latex. The label on the package that contains the product and the Instructions for Use (IFU) correctly states that the pessary is manufactured from latex rubber.
Potential Patient Demographic Error with Blank Patient ID Field
Belfiore Cheese was notified by their direct account that cheese received had noticeable metal fragments in the product.
Some eyelets broke from SwiveLock Anchor on insertion.
Product shipped proximate to or past the expiration date listed on the product label.
Undeclared milk, eggs, wheat and fish (anchovies).
Remote possibility that certain solutions in these lots may contain microscopic glass particles due to damage that occurred at the cylinder neck during the manufacturing process.
The Bakery Peanut Butter Chocolate Chunk Cookies may contain undeclared milk.
Product packaging may incorrectly include two bevel-tipped needles or two trocar-tipped needles instead of one diamond-tipped needle and one bevel-tipped needle.
The electrical controller, combined with motor, causes feedback, damaging a component on the control board, starting a fire.
Maple Mountain Group is recalling Stromaderm Age-Defying Serum because the product may contain microorganisms that may present a potential health hazard. Lot # 3925 - Pseudomonas aeruginosa and Candida boidinii were found. Lot #3785- Lactobacillus rhamnosus, Bacillus ginsengihumi, and Staphylococcus saprophyticus were found
Product is being recalled due to low pH value.
Rosa Foods is recalling Soylent Bar because it may contain undeclared milk (whey).
Organic Cocoa-Dusted Chocolate Ginger was recalled due to undeclared hazelnuts.
Microbial Contamination of Non-Sterile Products
mislabeled as 8mm tube but it is actually 9 mm in size. A 9mm subcomponent was erroneously substituted and etched as 8mm for the actual 8mm subcomponent part.
Six complaints were filed regarding loss of the Zimmer Biomet applied seal of a sterile Tyvek packaging. A breach in the packaging could lead to loss of sterility of the device.
Linear Broach Handle. Greatbatch Medical has received reports that that the product is breaking at the welds and that the locating pin at the distal end of the instrument is breaking off during use.
The Organic Basil Pesto with Watercress is recalled because it has the potential to be contaminated with Listeria monocytogenes.
Shrimp Burgers are recalled because the Ingredients statement declared butter, shrimp, cod, and/or Pollock but the Contains statement declared only fish & shellfish.
Crystallization: due to the presence of white, crystalline particulates, adhered to the side and bottom of the glass vials, which are comprised of principally dextrose and the buprenorphine active component.
Blood products, in which donor suitability was not adequately determined, were distributed.
Red blood cell, for which antigen testing was documented incorrectly, was distributed.

Code Info
P/N 18001-EBT-MP-D with FLIR A315 camera P/N 15102-EBT-MP-D wjth FLIR A615 camera TotalVision Software versions 1.6 1.7.1
Kloosterboer warehouse lot codes: D-033982 and D-033983.
Unique Device Identifier: 00888867160231 Batch Number: 10070003 - Expiration Date 9/30/2021
Unique Device Identifier: 00888867026865 Batch Number: 10072425 - Expiration Date 10/31/2018 Batch Number: 10073992 - Expiration Date 10/31/2018 Batch Number: 10077133 - Expiration Date 10/31/2018 Batch Number: 10078077 - Expiration Date 11/30/2018 Batch Number: 10078340 - Expiration Date 11/30/2018 Batch Number: 10075792 - Expiration Date 10/31/2018
Unique Device Identifier: 00888867026803 Batch Number: 10078258 Expiration Date 12/01/2021
Unique Device Identifier: 00888867027329 Batch Number: 10072597 - Expiration Date 10/31/2018 Batch Number: 10074288 - Expiration Date 10/31/2018 Batch Number: 10076753 - Expiration Date 10/31/2018 Batch Number: 10076852 - Expiration Date 10/31/2018 Batch Number: 10081420 - Expiration Date 11/30/2018 Batch Number: 10075965 - Expiration Date 10/31/2018 Batch Number: 10077252 - Expiration Date 10/31/2018 Batch Number: 10084027 - Expiration Date 12/31/2017
Unique Device Identifier: 00888867026766 Batch Number: 1078259 Expiration Date 11/30/2018
Unique Device Identifier: 00888867026926 Batch Number: 10072597 - Expiration Date 10/31/2021
Lot #202085 Stryker Product Number: 6001-420-000
s/n or lot number - Job Number lots 671494 - 672668
Lot 3925 Expiration Date: 10/2018 Lot 3785 Expiration Date: 5/2018
Lot number 21511158 with expiry date 10/20/2017
guaranteed fresh date of JUL 4 or prior; UPC 62930
guaranteed fresh date of JUL 4 or prior; UPC 64666
guaranteed fresh date of JUL 4 or prior; UPC 22050
guaranteed fresh date of JUL 4 or prior; UPC 5003
guaranteed fresh date of JUL 4 or prior; UPC 23935
Lot #: G7076PA, Expiration / Best Buy date: 02/2018.
Lot number on 5lb. bag: 17086. Product was offered to consumers through a self-serve bulk bin at retail store without any lot coding available.
Part Number: 900738 Lot Number (LN): 889990
Model numbers: 402282 and 402282J - Cobalt HV Bone Cement 402438 - Cobalt MV Bone Cement 402283J - Cobalt HV Bone Cement With Gentamicin 402438 Lot: 507830 402282J Lot: 668140 402282 Lot: 508220 402283J Lot: 189780
Lot # 5302A. Best By: January 18, 2017. Lot # 6174A. Best By: June 21, 2017. Lot # 6259A. Best By: September 23, 2017.