Z-0479-2026 Class II Ongoing

Recalled by Miach Orthopaedics — Westborough, MA

Recall Details

Product Type
Devices
Report Date
November 19, 2025
Initiation Date
February 2, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
167 units

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.

Distribution Pattern

US Nationwide distribution.

Code Information

Model/Catalog: 1000; UDI-DI: 00860002987804; Lot number: 7008409;