FDA Device recall Z-1009-2014
INTERLOCKING IM SCREW SML, MED and LRG
- FDA Device
- Class II
- terminated
- Published 2014-02-26
On 2014-02-26 the FDA classified a Class II recall of INTERLOCKING IM SCREW SML, MED and LRG 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-1009-2014 |
| 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
INTERLOCKING IM SCREW SML, MED and LRG; M/DN TIBIAL I/M NAIL 6 MM to 15 MM. Some items starting with codes 0022530, 0022531, 002532, 0022533, 0022534
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 | 60179289 60196075 60208629 60272379 60279637 60367538 60438316 60575719 60597680 60620340 60714150 60735642…60179289 60196075 60208629 60272379 60279637 60367538 60438316 60575719 60597680 60620340 60714150 60735642 60864016 60937504 61031036 61040654 61120277 61133164 61186040 61325064 61446262 61551621 60129673 60177185 60187385 60363817 60387525 60569948 60602446 60620341 60630482 60711126 60714151 60735643 60808002 60819266 60864018 60864019 60876889 60876890 60956565 61104687 61112613 61133165 61266235 61422229 61458906 61489975 60690743 60711143 60714152 60728336 60735644 60747675 60757046 60789824 60808003 60817590 60838120 60838121 60876892 60876893 60937495 60937496 61031038 61112614 61112651 61158629 61161384 60466661 60615939 60735645 60817572 60847807 61120278 61221431 61263174 61333468 60152966 60196077 60196079 60750994 60806391 60847809 60979630 61226089 61263175 61408290 61504079 60753364 60806396 60817586 60829585 60876926 60931129 61331079 60120568 60140390 60150071 60152967 |
|---|
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-1009-2014%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.