FDA Device recall Z-1823-2016
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-1823-2016 |
| 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. Screw, fixation, bone.
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 HAA60-11030 HAA60-13030 HAA60-15040 HAA60-16040 HAA60-18040 Lot #'s 016150 016210 165130 016230 133890 181600 133970 134000 181620 |
|---|
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-1823-2016%22
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