Drug recall
Neuro Combo Set Case The cases hold surgical instrumentation in place during handling and storage.
FDA recall event 72366 · Class II · Biomet Microfixation, LLC
Key facts
| Event ID | 72366 |
|---|---|
| Recall numbers | Z-0136-2016, Z-0137-2016 |
| Recalling firm | Biomet Microfixation, LLC |
| Product type | Devices |
| Products | Neuro Combo Set Case The cases hold surgical instrumentation in place during handling and storage., Thinflap System Case The cases hold surgical instrumentation in place during handling and storage. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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. |
| Initiation date | Aug 6, 2015 |
| Report date | Oct 28, 2015 |
| Termination date | Oct 13, 2017 |
| City | Jacksonville |
| State | FL |
| Country | United States |
| FEI number | 1032347 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: