Thinflap System Case The cases hold surgical instrumentation in place… — Class II medical device recall Z-0137-2016
Terminated recall by Biomet Microfixation, LLC, reported 2015-10-28, distributed nationwide. The lids on implant caddies within P/N 17-5000 and 19-5000 could not be opened by the user without application
| Recall number | Z-0137-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomet Microfixation, LLC, Jacksonville, FL, United States |
| Recall initiated | 2015-08-06 |
| Classified | 2015-10-20 |
| Reported by FDA | 2015-10-28 |
| Terminated | 2017-10-13 |
| Distributed | Nationwide (US) |
| Quantity | 5 units |
| Lot numbers | 101465 |
| Model numbers | 19-5000 |
Product
Thinflap System Case The cases hold surgical instrumentation in place during handling and storage.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0137-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.