PlainRecalls
FDA Devices Moderate Class II Terminated

3.5 X 10 CORT SCREW SELFT 3.5 X 12 CORT SCREW SELFT 3.5 X 14 CORT SCREW SELFT 3.5 X 16 CORT SCREW SELFT 3.5 X 18 CORT SCREW SELFT 3.5 X 20 CORT SCREW SELFT 3.5 X 22 CORT SCREW SELFT 3.5 X 24 CORT SCREW SELFT 3.5 X 26 CORT SCREW SELFT 3.5 X 28 CORT SCREW SELFT 3.5 X 30 CORT SCREW SELFT 3.5 X 32 CORT SCREW SELFT 3.5 X 34 CORT SCREW SELFT 3.5 X 36 CORT SCREW SELFT 3.5 X 38 CORT SCREW SELFT 3.5 X 40 CORT SCREW SELFT 3.5 X 45 CORT SCREW SELFT 3.5 X 50 CORT SCREW SELFT 3.5 X 55 CORT

Reported: February 26, 2014 Initiated: October 11, 2013 #Z-1044-2014

Product Description

3.5 X 10 CORT SCREW SELFT 3.5 X 12 CORT SCREW SELFT 3.5 X 14 CORT SCREW SELFT 3.5 X 16 CORT SCREW SELFT 3.5 X 18 CORT SCREW SELFT 3.5 X 20 CORT SCREW SELFT 3.5 X 22 CORT SCREW SELFT 3.5 X 24 CORT SCREW SELFT 3.5 X 26 CORT SCREW SELFT 3.5 X 28 CORT SCREW SELFT 3.5 X 30 CORT SCREW SELFT 3.5 X 32 CORT SCREW SELFT 3.5 X 34 CORT SCREW SELFT 3.5 X 36 CORT SCREW SELFT 3.5 X 38 CORT SCREW SELFT 3.5 X 40 CORT SCREW SELFT 3.5 X 45 CORT SCREW SELFT 3.5 X 50 CORT SCREW SELFT 3.5 X 55 CORT SCREW SELFT 3.5 X 60 CORT SCREW SELFT 3.5 X 75 CORT SCREW SELFT

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.

Details

Recalling Firm
Zimmer, Inc.
Units Affected
7,044,680 total
Distribution
Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Canary Islands, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Luxemburg, Netherlands, New Zealand, Norway, Portugal Reunion, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, Taiwan, Thailand, and United Kingdom.
Location
Warsaw, IN

Frequently Asked Questions

What product was recalled? ▼
3.5 X 10 CORT SCREW SELFT 3.5 X 12 CORT SCREW SELFT 3.5 X 14 CORT SCREW SELFT 3.5 X 16 CORT SCREW SELFT 3.5 X 18 CORT SCREW SELFT 3.5 X 20 CORT SCREW SELFT 3.5 X 22 CORT SCREW SELFT 3.5 X 24 CORT SCREW SELFT 3.5 X 26 CORT SCREW SELFT 3.5 X 28 CORT SCREW SELFT 3.5 X 30 CORT SCREW SELFT 3.5 X 32 CORT SCREW SELFT 3.5 X 34 CORT SCREW SELFT 3.5 X 36 CORT SCREW SELFT 3.5 X 38 CORT SCREW SELFT 3.5 X 40 CORT SCREW SELFT 3.5 X 45 CORT SCREW SELFT 3.5 X 50 CORT SCREW SELFT 3.5 X 55 CORT SCREW SELFT 3.5 X 60 CORT SCREW SELFT 3.5 X 75 CORT SCREW SELFT. Recalled by Zimmer, Inc.. Units affected: 7,044,680 total.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 26, 2014. Severity: Moderate. Recall number: Z-1044-2014.

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