Class II

Medical Device Recall: BEAR Implant (Bridge-Enhanced ACL Restoration); Model/Catalog: 1000;

Miach Orthopaedics · February 2, 2023

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.

Distribution

US Nationwide distribution.

States Affected

NATIONWIDE

Quantity Affected

167 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0479-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Miach Orthopaedics Medical Device Recall: BEAR Implant (Bridge-Enhanced ACL Restoration); Model/Catalog: 1000; | SafeCheck