FDA Device Intelligence
Home › Device types › QNI

Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair

FDA product code QNI · Class 2 · Orthopedic

1
Registered devices
35
Adverse events
2
Recalls
3
510(k) clearances

Devices with this code

BEAR Implant (Bridge-Enhanced ACL Restoration) — Miach Orthopaedics, Inc.

Recent recalls

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

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.