BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.
FDA Recall Z-0581-2025 · Posted 2024-11-29
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Recalling FirmSmith & Nephew Inc.
Recall StatusOpen, Classified
Product CodeMBI
Date Initiated2024-10-29
Product Quantity2,156 units
Reason for Recall
Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device.
Firm Action
An URGENT MEDICAL DEVICE RECALL NOTICE dated 10/29/24 was mailed to consignees. This notification instructed consignees to inspect their inventory for affected devices and quarantine them immediately. If product was further distributed consignees are to notify their customers of this recall and ensure recall actions are completed. Consignees are to complete the provided response form to facilitate the return of devices and email the completed form to [email protected]. Consignees who do not have product on hand are to complete and return the recall response form as well. Any questions about this recall are to be emailed to [email protected].
Root Cause
Package design/selection
Distribution Pattern
Worldwide - US Nationwide distribution in the states of AK, AL, IL, IN, KY, MD, MN, NC, NE, NH, NJ, TX and the countries of CA, CL, CN, EC, ES, GB, KZ, NO, PE, PL, RU, TR.
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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