Recall Z-1016-2014— Zimmer, Inc.
Class II · Terminated
Class II FDA medical device recall by Zimmer, Inc., initiated 2013-10-11, terminated 2017-04-14. FDA's recall record names no specific 510(k) clearance for this event. Product: MOORE HIP PROS LONG FENES, MOORE HIP PROS NRW STR FE, MOORE HIP PROS STR FENEST, THOMPSON HIP PROSTHESIS 3, 4, 5 and 6.. Reason: 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..
- Recalling firm
- Zimmer, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-10-11
- Terminated
- 2017-04-14
- Firm location
- Warsaw, IN, United States
Product description
MOORE HIP PROS LONG FENES, MOORE HIP PROS NRW STR FE, MOORE HIP PROS STR FENEST, THOMPSON HIP PROSTHESIS 3, 4, 5 and 6.
Reason for recall
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.
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