FDA Device recall Z-0592-2014
TIB NAIL
- FDA Device
- Class II
- terminated
- Published 2014-01-08
On 2014-01-08 the FDA classified a Class II recall of TIB NAIL by Zimmer, citing based on a review of historic packaging validations, it was determined that a subset of product packaged at a Zimmer facility required testing to ensure that previously packaged p….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0592-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-11-05 |
| Published | 2014-01-08 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Zimmer |
| Distribution | n/a |
Product
TIB NAIL
Reason
Based on a review of historic packaging validations, it was determined that a subset of product packaged at a Zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity. This testing determined that a packaging tray configuration which consists of an inner and outer sterile tray, resulted in failure
Identifiers
| code_info | Item #'s: 32-8553-311-59 32-8553-311-61 32-8553-311-63 32-8553-311-65 Lot #s: All lots with an expiration date prior to July 24, 2023 |
|---|
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-0592-2014%22
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