FDA Device recall Z-0479-2026
BEAR Implant (Bridge-Enhanced ACL Restoration)
- FDA Device
- Class II
- ongoing
- Published 2025-11-19
On 2025-11-19 the FDA classified a Class II recall of BEAR Implant (Bridge-Enhanced ACL Restoration) by Miach Orthopaedics, citing the field action was initiated in February of 2023 and was limited to the affected lot from sales force trunk stock only.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0479-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-02-02 |
| Published | 2025-11-19 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Miach Orthopaedics |
| Distribution | US |
Product
BEAR Implant (Bridge-Enhanced ACL Restoration); Model/Catalog: 1000;
Reason
The field action was initiated in February of 2023 and was limited to the affected lot from sales force trunk stock only.
Identifiers
| code_info | Model/Catalog: 1000; UDI-DI: 00860002987804; Lot number: 7008409; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0479-2026%22
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