Zimmer ITST" INTERTROCHANTERIC/SUBTROCHANTERIC FIXATION LOCKING BOLT EXTRACTOR - NONSTERILE Zimmer, Warsaw, IN 46580, U.S.A. The ITST Intertrochanteric/Subtrochanteric Fixation Locking Bolt Extractor instrument is a reusable surgical instrument used to separate the femoral nail from the locking bolt after nail implantation/fixation in trauma surgeries
FDA Recall Z-2289-2010 · Posted 2010-08-26
Recalling FirmZimmer Inc.
Recall StatusTerminated
Product CodeLXH
Date Initiated2010-07-05
Date Terminated2011-02-25
Product Quantity20 individual units
Reason for Recall
Instruments were manufactured with the incorrect grade of steel, increasing the potential for fracture during use.
Firm Action
Zimmer sent "Urgent: Device Removal" letters dated July 8, 2010 to consignees identifying the potential for fracture of the device. Consignees were instructed to inventory affected product and record on the Inventory Return Certification Form, to document users of the affected device on the User Facility/HCP Form, and return both forms by fax or email. Affected product is to be returned to Zimmer with a copy of the Inventory Return Certification Form. Returned product will be destroyed. Each of the affected consignees will be provided with a new instrument, manufactured with the correct 17-4 stainless steel.
Consignees can contact Zimmer at 800-613-6131 or 574-372-4463
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide Distribution in the countries of US, Canada, Spain, Germany, and Great Britain.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.