Z-0479-2026Class II

Miach Orthopaedics

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm

Miach Orthopaedics

Product type

Device

Status

Ongoing

Report date

2025-11-19

Distribution

US Nationwide distribution.

Firm state

Product quantity

167 units

Initiated by

Voluntary: Firm initiated

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.

Product description

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

Code / lot info

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

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →