Zimmer, Insall/Burstein II Modular Knee System, Tibial Wedge and 2 Screws, Size 59, 7 Deg. x 9.5 mm Height, Tivanium TI-6AL-4V Alloy, sterile; REF 5220-62-01.
FDA Recall Z-0555-2010 · Posted 2009-12-22
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Recalling FirmZimmer Inc.
Recall StatusTerminated
Product CodeHSX
Date Initiated2009-02-26
Date Terminated2011-02-28
Product Quantity13
Reason for Recall
Smaller diameter screws than required were included in the package.
Firm Action
Zimmer notified consignees by recall letter dated 2/25/09 instructing them to cease use of the device and to return it. Zimmer distributors and international accounts were notified by email on 2/26/09.
Root Cause
Process control
Distribution Pattern
USA (Connecticut, Indiana, Pennsylvania), Australia, Serbia, Spain, Switzerland and the United Kingdom.
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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