FDA Device recall Z-0277-2014
VerSys¿ Cemented Revision Calcar (CRC) Hip System Femoral Stems VerSys Heritage Hip System Revision Femoral Stems
- FDA Device
- Class II
- terminated
- Published 2013-11-20
On 2013-11-20 the FDA classified a Class II recall of VerSys¿ Cemented Revision Calcar (CRC) Hip System Femoral Stems VerSys Heritage Hip System Revision Femoral Stems by Zimmer, citing based on a review of historic packaging validations, it was determined that a subset of product packaged in one of the clean rooms at a single Zimmer facility required testing to….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0277-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-08-28 |
| Published | 2013-11-20 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Zimmer |
| Distribution | US |
Product
VerSys¿ Cemented Revision Calcar (CRC) Hip System Femoral Stems VerSys Heritage Hip System Revision Femoral Stems. Indicated for total hip arthroplasty.
Reason
Based on a review of historic packaging validations, it was determined that a subset of product packaged in one of the clean rooms at a single Zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity. The number of samples required for packaging testing (seal integrity and seal strength) to provid
Identifiers
| code_info | 00369673 00369898 00369984 00369985 00369988 00369989 00369995 00369996 00369997 00369998 00370074 00370082…00369673 00369898 00369984 00369985 00369988 00369989 00369995 00369996 00369997 00369998 00370074 00370082 00370103 00370161 00370162 00370163 00370165 00370166 00370240 00370241 00370242 00370244 00370245 00370246 00370285 00370299 00370300 00370301 00370371 00370374 00370376 00370377 00370378 00370379 00370382 00370405 00370406 00370407 00370409 00370411 00370417 00370428 00370471 00370475 00370620 00370621 00370906 60486158 60495799 60495801 60545572 60545573 60545574 60565682 60565683 60589392 60589393 60589394 60609870 60609871 60644570 60644588 60644589 60644590 60658265 60658266 60661955 60661956 60661957 60661958 60661959 60661960 60661962 60661964 60661965 60661966 60661968 60661971 60661974 60676452 60676454 60676455 60676456 60676457 60676459 60676460 60676462 60676463 60676464 60676467 60712462 60712463 60712464 60712465 60712468 60712469 60726764 60737992 60737996 60745879 |
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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-0277-2014%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.