Miach Orthopaedics recalls BEAR Implant. Model Number: 1000.

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.

Notification to Sales Representatives and consignees began on about 12/31/2025 via email and letter titled URGENT MEDICAL DEVICE RECALL NOTIFICATION. Consignees were instructed to identify and quarantine all unused inventory of the affected lot, discontinue distribution of the affected lot, return all unused affected product, and complete and return the provided Recall Acknowledgement Form. Additionally, consignees were requested to notify customers if the affected lot was further distributed.

• FDA enforcement recordOfficial FDA database entry for Z-1220-2026
• FDA 510(k) clearance · K243578The device's official FDA premarket clearance record
• FDA device classification · QNIOfficial FDA classification for this device type
• CFR regulation · 21 CFR 888.3044The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Miach OrthopaedicsSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.