Date Initiated by Firm |
July 05, 2010 |
Date Posted |
August 26, 2010 |
Recall Status1 |
Terminated 3 on February 25, 2011 |
Recall Number |
Z-2289-2010 |
Recall Event ID |
56328 |
Product Classification |
Orthopedic manual surgical instrument - Product Code LXH
|
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 |
Code Information |
Catalog No. 00-2258-051-01; Lot No. 53951300; Manufactured 8/8/2002 |
Recalling Firm/ Manufacturer |
Zimmer Inc. 1800 W Center St Warsaw IN 46580-2304
|
For Additional Information Contact |
574-267-6131
|
Manufacturer Reason for Recall |
Instruments were manufactured with the incorrect grade of steel, increasing the potential for fracture during use.
|
FDA Determined Cause 2 |
Nonconforming Material/Component |
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 |
Quantity in Commerce |
20 individual units |
Distribution |
Worldwide Distribution in the countries of US, Canada, Spain, Germany, and Great Britain. |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|