OSS (Orthopedic Salvage System) RS Non-Modular Long Tibial Base, Porous Coated, 71mm x 10 x 160mm, Co-CR-MO/Ti-6AL-4V alloy, sterile; Part 161043. Implant is part of a system used to replace the tibial portion of the knee joint.
FDA Recall Z-2213-2008 · Posted 2008-09-17
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Recalling FirmBiomet, Inc.
Recall StatusTerminated
Product CodeKRO
Date Initiated2007-11-07
Date Terminated2009-03-13
Product Quantity22
Reason for Recall
Mislabeled as to size: Product is labeled as reduced size, but is actually standard size.
Firm Action
Consignees were notified by an Urgent Medical Device Recall Notice letter dated 11/7/07. The letter required that use of the product be immediately discontinued and that components be returned to Biomet. Letters to hospital administrators and the five implanting surgeons were issued on/or about 5/6/08 advising them of the problem and to perform patient evaluations.
Root Cause
Labeling mix-ups
Distribution Pattern
Nationwide Distribution --- including states of California, Florida, Illinois, Indiana, Massachusetts, Missouri, New Jersey, Oklahoma, Pennsylvania, Texas, Virginia and Washington.
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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