Z-2289-2010

Zimmer ITST" INTERTROCHANTERIC/SUBTROCHANTERIC FIXATION LOCKING BOLT EXTRACTOR - NONSTERILE Zimmer, Warsaw...

Name: Z-2289-2010 Zimmer ITST" INTERTROCHANTERIC/SUBTROCHANTERIC FIXATION LOCKING BOLT EXTRACTOR - NONSTERILE Zimmer, Warsaw...
Creator: Zimmer Inc.
Published: 2010-07-05
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2010-07-05 / Terminated / root cause: manufacturing process

FDA source

Zimmer Inc. began a recall of Zimmer ITST" INTERTROCHANTERIC/SUBTROCHANTERIC FIXATION LOCKING BOLT EXTRACTOR - NONSTERILE Zimmer, Warsaw, IN 46580, U.S.A. The ITST... on 2010-07-05. The reason FDA records is "Instruments were manufactured with the incorrect grade of steel, increasing the potential for fracture during use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2289-2010
Status: Terminated
Initiated: 2010-07-05
Posted: 2010-08-26
Terminated: 2011-02-25
Recalling firm: Zimmer GmbH
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
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: Instruments were manufactured with the incorrect grade of steel, increasing the potential for fracture during use.
Root cause tag: manufacturing process
FDA 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 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.
Product codes and lots: Catalog No. 00-2258-051-01; Lot No. 53951300; Manufactured 8/8/2002

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)