FDA Device recall Z-1817-2016
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-1817-2016 |
| 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. Plate, 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 24616 131212112 131212113 131212114 131212116 131212118 131212216 131212218 131212220 131212222 131…Part #'s 24616 131212112 131212113 131212114 131212116 131212118 131212216 131212218 131212220 131212222 131212224 131212316 131212318 131212320 131212322 856135016 856135018 856135020 856135022 856135024 856135026 856135028 856135030 856135034 856135036 856135038 856135040 856135042 Lot #'s 606160 729130 664900 752650 752660 664910 664930 752680 664950 752690 752720 664990 665020 665040 665060 665070 665090 665100 665120 665130 758430 758500 758520 758540 758550 758570 758670 758680 758700 758710 758720 758730 758740 |
|---|
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-1817-2016%22
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