Zimmer Steinmann Pins, 7/64 in. (2.8 mm) diameter, 9 in. (229mm) length, style 6, nonsterile, qty 6, Zimmer, Warsaw, IN;

FDA device recall Z-1481-2009 · posted 2009-06-26 · Terminated

Recall details

Recalling firm

Zimmer Inc.

Reason for recall

The package contains pins with an incorrect diameter.

Action taken

Zimmer, Inc. issued an "Urgent: Device Recall" letter informing users of the affected product. Users were instructed to locate and quarantine all unused devices and ship them to the firm with a completed Inventory Return Certification form. Return Certification forms are also to be sent via fax to Zimmer, Inc. at 1-574-372-4265. For further questions, contact Zimmer, Inc. at 1-800-613-6131.

Root cause

Packaging process control

Status

Terminated

Product code

HTY

Quantity affected

37

Distribution

Worldwide Distribution -- US including states of CA, GA, IL, MA, MO, OR, TX and WI and Japan.

Date initiated

2009-05-01

Date posted

2009-06-26

Date terminated

2009-11-12

Location

Warsaw, IN