FDA Device recall Z-1007-2014
M/DN R-F IM NAIL 9MM DIA , 10 MM, 11 MM, 12 MM, 13 MM and 14 MM. Item codes starting with 0022400
- FDA Device
- Class II
- terminated
- Published 2014-02-26
On 2014-02-26 the FDA classified a Class II recall of M/DN R-F IM NAIL 9MM DIA , 10 MM, 11 MM, 12 MM, 13 MM and 14 MM. Item codes starting with 0022400 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-1007-2014 |
| 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
M/DN R-F IM NAIL 9MM DIA , 10 MM, 11 MM, 12 MM, 13 MM and 14 MM. Item codes starting with 0022400
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 | 368278 61111052 61159202 61228030 61276758 61307948 61111052R 368279 60275442 60994837 61111053 61255583 61…368278 61111052 61159202 61228030 61276758 61307948 61111052R 368279 60275442 60994837 61111053 61255583 61294523 61556944 368280 61098707 61178911 61284930 61298508 61342119 61546150 60158048 60281123 61075888 61159203 61220139 61290248 61332792 61727932 368490 60158049 60506370 60741224 60960320 61111054 61120925 61143374 61220140 61298509 61143374R 368281 60114142 60232597 60518286 60960628 60960818 61220141 61266215 61281313 61317747 60175525 60281124 60958453 60960815 61140792 61159204 61275565 61317749 60960815R 61275565R 368311 368493 60082894 60281333 61075889 61111055 61159205 61220142 61290251 61338952 368112 368494 60186975 60253467 60703526 60994877 61075890 61111056 61143376 61220143 61275566 60186975R 60253467R 60703526R 368284 368285 368948 60082895 60186976 60305055 60958452 60960816 61140794 61271223 61281317 61313785 367853 368496 60376357 60506371 60725289 61075891 6 |
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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-1007-2014%22
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