BEAR Implant (Bridge-Enhanced ACL Restoration); Model/Catalog: 1000;
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Medium |
| Status | ongoing |
| Recall date | February 02, 2023 |
| Reported | November 19, 2025 |
| Recalling firm | Miach Orthopaedics |
| Country / region | United States MA |
Hazard
The field action was initiated in February of 2023 and was limited to the affected lot from sales force trunk stock only.
Affected products
- BEAR Implant (Bridge-Enhanced ACL Restoration); Model/Catalog: 1000;
Related recalls
3DIMENSIONS MAMMOGRAPHY SYSTEM; Model Numbers: 3DM-SYS-INTL2D, 3DM-SYS-INTL2D-MOB, 3DM-SYS-INTL2D-NS, 3DM-SYS-QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp.Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,EH Model/Catalog Number: 11-1424 Software Version: Revolution Apex Plus, X-ray Computed Tomography, Model Number 5590000-25BW Webster Duo-Decapolar, Product Number D728260RT; REPROCESSED ELECTROPHYSIOLOGY CATHETER