Zimmer ITST" INTERTROCHANTERIC/SUBTROCHANTERIC FIXATION LOCKING BOLT EXTRACTOR - NONSTERILE Zimmer, Warsaw, IN 46580, U.

FDA device recall Z-2289-2010 · posted 2010-08-26 · Terminated

Recall details

Recalling firm

Zimmer Inc.

Reason for recall

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

Action taken

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

Status

Terminated

Product code

LXH

Quantity affected

20 individual units

Distribution

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

Date initiated

2010-07-05

Date posted

2010-08-26

Date terminated

2011-02-25

Location

Warsaw, IN