FDA Device recall Z-1004-2014
Item codes starting with 001930 LAG SCR 12.7D X 55MM SHOR up to 155 MM, LAG SCR 12.7D X 55 MM SHO up to 100MM, LAG SCR 12.7D X 55MM STAN up…
- FDA Device
- Class II
- terminated
- Published 2014-02-26
On 2014-02-26 the FDA classified a Class II recall of Item codes starting with 001930 LAG SCR 12.7D X 55MM SHOR up to 155 MM, LAG SCR 12.7D X 55 MM SHO up to 100MM, LAG SCR 12.7D X 55MM STAN up… by Zimmer, citing 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 deter….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1004-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-10-11 |
| Published | 2014-02-26 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Zimmer |
| Distribution | US |
Product
Item codes starting with 001930 LAG SCR 12.7D X 55MM SHOR up to 155 MM, LAG SCR 12.7D X 55 MM SHO up to 100MM, LAG SCR 12.7D X 55MM STAN up to 155 MM, LAG SCR 15.8D X 55MM LARG up to 155 MM
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.
Identifiers
| code_info | 61484349 62124275 62157179 61077209 61337135 61484350 60555611 60747379 60874833 61142854 61142854R 60325552…61484349 62124275 62157179 61077209 61337135 61484350 60555611 60747379 60874833 61142854 61142854R 60325552 60293083 60879683 61284330 61286943 60085527 60436025 60513856 60879684 61284331 61286947 60145167 60186855 60210921 60815940 60879685 60152929 60293084 60483144 60523344 60483145 60523345 60483145R 60440756 60483146 60523346 61142856 60483147 60523347 60536820 60483148 60523350 60483149 60523353 60483150 60523355 60536821 60483151 60483152 60523360 60483153 60523364 60483154 60523365 61067755 60483155 60523369 60132504 60165597 60206470 60293086 60387521 60452004 60488952 60572992 60653075 60671959 60812149 60984699 61004201 61040107 61092997 61099399 61104820 61142860 61224794 61283207 60127012 60140321 60152930 60208488 60265677 60281409 60293087 60323242 60425131 60452005 60488953 60523371 60561146 60653078 60671960 60812150 60848590 61002194 61002195 61026422 61026423 61026424 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1004-2014%22
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