Reported Feb 26, 2014 · Terminated
PERI SCR. 3.5MM X 10MM PERI SCR. 3.5MM X 12MM PERI SCR. 3.5MM X 14MM PERI SCR 3.5MM X 44MM STE PERI SCR. 3.5MM X 65MM…
Zimmer, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zimmer, Inc. · 345 E Main St · Warsaw, IN · 46580-2746
Is this the product you have?
- PERI SCR. 3.5MM X 10MM PERI SCR. 3.5MM X 12MM PERI SCR. 3.5MM X 14MM PERI SCR 3.5MM X 44MM STE PERI SCR. 3.5MM X 65MM PERI. SCR 4.0MM X24MM PERI. SCR 4.0MM X40MM PERI SCR. 4.0MMX14MM FULL PERI SCR. 4.0MMX32MM FULL PERI SCR. 4.0MMX38MM FULL 3.5MM CORT SCR X 10MM 3.5MM CORT SCR X 12MM 3.5MM CORT SCR X 14MM 3.5MM CORT SCR X 16MM 3.5MM CORT SCR X 18MM 3.5MM CORT SCR X 20MM 3.5MM CORT SCR X 22MM 3.5MM CORT SCR X 24MM 3.5MM CORT SCR X 26MM 3.5MM CORT SCR X 28MM 3.5MM CORT SCR X 30MM 3.5MM CORT SCR X 32MM 3.5MM CORT SCR X 34MM 3.5MM CORT SCR X 36MM 3.5MM CORT SCR X 38MM 3.5MM CORT SCR X 40MM 3.5MM CORT SCR X 42MM 3.5MM CORT SCR X 44MM 3.5MM CORT SCR X 46MM 3.5MM CORT SCR X 48MM 3.5MM CORT SCR X 50MM 3.5MM CORT SCR X 52MM 3.5MM CORT SCR X 54MM 3.5MM CORT SCR X 56MM 3.5MM CORT SCR X 58MM 3.5MM CORT SCR X 60MM 3.5MM CORT SCR X 65MM 3.5MM CORT SCR X 70MM 3.5MM CORT SCR X 75MM 3.5MM CORT SCR X 80MM 3.5MM CORT SCR X 85MM 3.5MM CORT SCR X 90MM 3.5MM CORT SCR X 100MM 3.5MM CORT SCR X 105MM 3.5MM CORT SCR X 110MM CANC SCR 4.0MM X 10MM CANC SCR 4.0MM X 10MM FUL CANC SCR 4.0MM X 12MM CANC SCR 4.0MM X 12MM FUL CANC SCR 4.0MM X 14MM CANC SCR 4.0MM X 14MM FUL CANC SCR 4.0MM X 16MM CANC SCR 4.0MM X 16MM FUL CANC SCR 4.0MM X 18MM CANC SCR 4.0MM X 18MM FUL CANC SCR 4.0MM X 20MM CANC SCR 4.0MM X 20MM FUL CANC SCR 4.0MM X 22MM CANC SCR 4.0MM X 22MM FUL CANC SCR 4.0MM X 24MM CANC SCR 4.0MM X 24MM FUL CANC SCR 4.0MM X 26MM CANC SCR 4.0MM X 26MM FUL CANC SCR 4.0MM X 28MM CANC SCR 4.0MM X 28MM FUL CANC SCR 4.0MM X 30MM CANC SCR 4.0MM X 30MM FUL CANC SCR 4.0MM X 32MM CANC SCR 4.0MM X 32MM FUL CANC SCR 4.0MM X 34MM CANC SCR 4.0MM X 34MM FUL CANC SCR 4.0MM X 36MM CANC SCR 4.0MM X 36MM FUL CANC SCR 4.0MM X 38MM CANC SCR 4.0MM X 38MM FUL CANC SCR 4.0MM X 40MM CANC SCR 4.0MM X 40MM FUL
- Lot codes and dates
116 of 116 codes
613371616125149861251499612204326155328861966252619662576085680260871924608719466083723661168818611688216125134061168823612513416116882561216588612475266116882761216589612475276116882961216590612475286116883061216591612475296116883161247530611688336121659361247531611688356124753261168837612165966124753361168839611688416116884261168843611688456124753661168847612237056116884961168850611688526116885461168856611688586116885961168860611688616116886261567437614115796167838361678382
- Amount recalled
- 7,044,680 total
This recall covers 44 products
The agency filed one notice per product. You are reading one of them; the other 43 are below.
31 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.
This product could cause temporary or reversible health problems — stop using it.
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