FDA Device recall Z-1825-2016
Various trauma and sports medicine instruments and implants
- FDA Device
- Class II
- terminated
- Published 2016-06-01
On 2016-06-01 the FDA classified a Class II recall of Various trauma and sports medicine instruments and implants by Biomet, citing insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If th….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1825-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-04-01 |
| Published | 2016-06-01 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Biomet |
| Distribution | US |
Product
Various trauma and sports medicine instruments and implants. Appliance, fixation, nail/blade/plate combination, multiple component.
Reason
Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non-sterile and is used or implanted, it may lead to an infection.
Identifiers
| code_info | Part #'s 200185 200195 200200 16-235136 Lot #'s 711680 655630 691980 722690 692000 722670 744670 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1825-2016%22
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