Recall Z-2289-2010 ยท LXH Orthopedic Manual Surgical Instrument
Zimmer Inc.
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
| Date | Aug 26, 2010 (initiated Jul 5, 2010) |
| Status | Terminated |
| Reason | Instruments were manufactured with the incorrect grade of steel, increasing the potential for fracture during use. |
| Root cause | 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 |
| Quantity | 20 individual units |
| Distribution | Worldwide Distribution in the countries of US, Canada, Spain, Germany, and Great Britain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.