FDA Device recall Z-1011-2014
M/DN HUMERAL I/M NAIL. Sizes from 6 MM to 13 MM. Codes starting with 0022541, 002542 and 0022543
- FDA Device
- Class II
- terminated
- Published 2014-02-26
On 2014-02-26 the FDA classified a Class II recall of M/DN HUMERAL I/M NAIL. Sizes from 6 MM to 13 MM. Codes starting with 0022541, 002542 and 0022543 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-1011-2014 |
| 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 HUMERAL I/M NAIL. Sizes from 6 MM to 13 MM. Codes starting with 0022541, 002542 and 0022543.
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 | 367948 60314382 60630218 60691787 61053255 61064495 61117719 61303810 61367343 61434774 368764 369138 60219…367948 60314382 60630218 60691787 61053255 61064495 61117719 61303810 61367343 61434774 368764 369138 60219125 60391605 60468238 60645301 61040164 61040166 61092425 61271218 61298490 61332788 61415337 61565527 61711271 61748698 61565527R 368397 60136443 60269633 60393450 60894576 61031591 61079877 61191197 61242951 61294517 61490690 61578055 367232 367951 369139 60518287 60747414 61026918 61092426 61191198 61244794 61275552 61332789 61413348 61490691 00367232R 367735 367952 60205391 60439856 60917345 61049665 61117720 61191199 61260863 61328159 61394802 61428545 367953 368447 369593 60797052 60917346 61069777 61172854 61290214 61382432 61413349 367725 367954 369141 60820229 60969982 60970713 61290216 61382436 00367725R 367955 60222667 60231603 60977563 61191201 61382437 61445338 60231603R 367956 60205392 60969976 60999538 61275553 61344244 61512881 367933 369142 60165691 60269651 6058 |
|---|
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-1011-2014%22
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