FDA Device recall Z-1022-2014
NEXGEN MIS TIBIA PLATE PR NEXGEN TAPER PLUG NEXGEN PRECOAT PEG TIB PL NEXGEN MICRO ALL-POLY PAT NEXGEN ALL-POLY PATELLA, NEXGEN PRECOAT STE…
- FDA Device
- Class II
- terminated
- Published 2014-02-26
On 2014-02-26 the FDA classified a Class II recall of NEXGEN MIS TIBIA PLATE PR NEXGEN TAPER PLUG NEXGEN PRECOAT PEG TIB PL NEXGEN MICRO ALL-POLY PAT NEXGEN ALL-POLY PATELLA, NEXGEN PRECOAT STE… 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-1022-2014 |
| 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
NEXGEN MIS TIBIA PLATE PR NEXGEN TAPER PLUG NEXGEN PRECOAT PEG TIB PL NEXGEN MICRO ALL-POLY PAT NEXGEN ALL-POLY PATELLA, NEXGEN PRECOAT STEMMED TI NEXGEN OPTION STEMMED TIB NEXGEN STRAIGHT STEM EXT NEXGEN SHARP FLUTED STEM NEXGEN FLUTED STEM EXT, 1 NEXGEN FLUTED STEM EXT, 2 NEXGEN CEMENTED STEM EXT
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 | 61424993 61507222 61543969 61442278 61497511 61518148 61518149 61627190 61454951 61454952 61507223 61558358…61424993 61507222 61543969 61442278 61497511 61518148 61518149 61627190 61454951 61454952 61507223 61558358 61627192 61627198 61627202 61643930 61721669 61442310 61459958 61475125 61543975 61567342 61627206 61678232 61678233 61442319 61454955 61459970 61475130 61518182 61543977 61567344 61627260 61658886 61414605 61451226 61479488 61479489 61479490 61518197 61518198 61592093 61643938 61682157 61685470 61721675 61442326 61459971 61459972 61488229 61518205 61543979 61658887 61658888 61424999 61543980 60877120 60893096 60903660 60917693 60917702 60917706 60917708 60917709 60917710 60917711 60917712 60917713 60918890 60918891 60918895 60918896 60918898 60918899 60922337 60922338 60922340 60922341 60922342 60922343 60922345 60922347 60922348 60927295 60927296 60927297 60927299 60927301 60927302 60927303 60927304 60927305 60927307 60927310 60927311 60931982 60931984 60936965 60936970 60936971 |
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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-1022-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.