Recall Z-0479-2026— Miach Orthopaedics
Class II · Ongoing
Class II FDA medical device recall by Miach Orthopaedics, initiated 2023-02-02. It names one FDA 510(k) clearance: K243578. 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..
- Recalling firm
- Miach Orthopaedics
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-02-02
- Firm location
- Westborough, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
BEAR Implant (Bridge-Enhanced ACL Restoration); Model/Catalog: 1000;
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.