BEAR Implant. Model Number: 1000.
FDA Recall Z-1220-2026 · Posted 2026-01-29
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Recalling FirmMiach Orthopaedics
Recall StatusOpen, Classified
Product CodeQNI
Date Initiated2025-12-31
Product Quantity284 units
Reason for Recall
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.
Firm Action
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.
Root Cause
Process control
Distribution Pattern
US Nationwide distribution in the states of AK, CA, CO, CT, FL, GA, IL, MA, MD, ME, MI, MN, MO, NC, NJ, NY, OH, OR, TX, VA, WA, WI.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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