FDA Device recall Z-1815-2016
Various trauma and sports medicine instruments and implants. guide, surgical, instrument
- 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. guide, surgical, instrument 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-1815-2016 |
| 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. guide, surgical, instrument
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 281001080 281001100 35-351208 35-351534 35-351564 Lot #'s 606200 606210 606220 614280 661690 661…Part #'s 281001080 281001100 35-351208 35-351534 35-351564 Lot #'s 606200 606210 606220 614280 661690 661700 661660 755290 764390 764400 621850 |
|---|
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-1815-2016%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.