FDA Device recall Z-0137-2016
Thinflap System Case The cases hold surgical instrumentation in place during handling and storage
- FDA Device
- Class II
- terminated
- Published 2015-10-28
On 2015-10-28 the FDA classified a Class II recall of Thinflap System Case The cases hold surgical instrumentation in place during handling and storage by Biomet Microfixation, citing the lids on implant caddies within P/N 17-5000 and 19-5000 could not be opened by the user without application of undesirable/unexpected excessive force.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0137-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-08-06 |
| Published | 2015-10-28 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Biomet Microfixation |
| Distribution | US |
Product
Thinflap System Case The cases hold surgical instrumentation in place during handling and storage.
Reason
The lids on implant caddies within P/N 17-5000 and 19-5000 could not be opened by the user without application of undesirable/unexpected excessive force.
Identifiers
| code_info | Lot Code # 101465 Model # 19-5000 |
|---|
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-0137-2016%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.