Bio-Modular Humeral Head 48mm x 24mm Ti 6AI4V/Ion Implanted (Orthopedic Implant) Product Usage: The OSS Knee Reamer Sleeves are primarily used to guide the bullet tip of cylindrical reamers during the tibial preparation in OSS procedures. They are reusable.
FDA Recall Z-0474-2013 · Posted 2012-12-05
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Recalling FirmBiomet, Inc.
Recall StatusTerminated
Product CodeKWT
Date Initiated2012-11-01
Date Terminated2013-08-29
Product Quantity4
Reason for Recall
The items in this lot are missing the ion implantation feature. The surface of the head may be softer and more prone to scratching, which in tum could potentially cause higher wear of the poly bearing. Increased wear could potentially lead to a shorter implant life.
Firm Action
Biomet, Inc. sent an URGENT MEDICAL DEVICE RECALL NOTICE dated November 1, 2012 to all affected consignees. The letter identified the affected product, problem and actions to be taken. The notification letter instructed the surgeon to montior the patient as their is a potential for increased wear which have an unknown effect on implant life. For questions call 574-372-1570.
Root Cause
Process control
Distribution Pattern
USA Nationwide Distribution in the state of 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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