Drug recall
BEAR Implant (Bridge-Enhanced ACL Restoration); Model/Catalog: 1000;
FDA recall event 97742 · Class II · Miach Orthopaedics
Key facts
| Event ID | 97742 |
|---|---|
| Recall numbers | Z-0479-2026 |
| Recalling firm | Miach Orthopaedics |
| Product type | Devices |
| Products | BEAR Implant (Bridge-Enhanced ACL Restoration); Model/Catalog: 1000; |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The field action was initiated in February of 2023 and was limited to the affected lot from sales force trunk stock only. |
| Initiation date | Feb 2, 2023 |
| Report date | Nov 19, 2025 |
| City | Westborough |
| State | MA |
| Country | United States |
| FEI number | 3020652309 |
At a glance
- 1–9 Products in this recall
- 1–9 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: