Class II — Biomet Microfixation, LLC
| Recalling firm | BIOMET MICROFIXATION |
|---|---|
| Registered facility | BIOMET MICROFIXATION (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| 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. |
| Product | Neuro Combo Set Case The cases hold surgical instrumentation in place during handling and storage. |
| Quantity | 37 cases |
| Distribution | Nationwide Distribution including CA, FL, OK, NY, NC, and IL. |
| Initiated | 2015-08-06 |
| Classified | 2015-10-20 |
| Terminated | 2017-10-13 |
| Recall number | Z-0136-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Biomet Microfixation, LLC (Z-0136-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/72366/
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