—#93239

Product

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 product code: LXH — Orthopedic Manual Surgical Instrument
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Catalog No. 00-2258-051-01; Lot No. 53951300; Manufactured 8/8/2002

Why it was recalled

Instruments were manufactured with the incorrect grade of steel, increasing the potential for fracture during use.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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

Recalling firm

Firm: Zimmer Inc.
Address: 1800 W Center St, Warsaw, Indiana 46580-2304

Distribution

Distribution pattern: Worldwide Distribution in the countries of US, Canada, Spain, Germany, and Great Britain.

Timeline

Recall initiated: 2010-07-05
Posted by FDA: 2010-08-26
Terminated: 2011-02-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #93239. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.