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BEAR Implant (Bridge-Enhanced ACL Restoration)

Miach Orthopaedics, Inc. · Model 1000 · UDI-DI 00860002987804

QNI Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

Resorbable implant for anterior cruciate ligament (ACL) repair. A resorbable implant for anterior cruciate ligament (ACL) repair is a degradable material that allows for healing of a torn ACL that is biomechanically stabilized by traditional suturing procedures. The device is intended to protect the biological healing process from the surrounding intraarticular environment and not intended to replace biomechanical fixation via suturing. This classification includes devices that bridge or surround the torn ends of a ruptured ACL.

Recalls

Date	Firm	Reason
2025-12-31	Miach Orthopaedics	Incorrect expiration date on label that extends beyond the product's documented/approved shelf life. With an incorrect expiration date, the UDI will also be incorrect.
2023-02-02	Miach Orthopaedics	The field action was initiated in February of 2023 and was limited to the affected lot from sales force trunk stock only.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.