Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

BEAR Implant. Model Number: 1000. Recalled by Miach Orthopaedics Due to Incorrect expiration date on label that extends beyond...

Date: December 31, 2025
Company: Miach Orthopaedics
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Miach Orthopaedics directly.

Affected Products

BEAR Implant. Model Number: 1000.

Quantity: 284 units

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Miach Orthopaedics

Miach Orthopaedics has 2 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report