Zimmer Inverse/Reverse Screw system,

FDA device recall Z-0228-2013 · posted 2012-11-06 · Terminated

Recall details

Recalling firm

Zimmer, Inc.

Reason for recall

Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the info

Action taken

Zimmer, Inc. sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated September 4, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. A Certificate of Acknowledgement Form was attached for customers to complete and return via fax to Zimmer, Inc. at 574 372-4265.

Root cause

Error in labeling

Status

Terminated

Product code

KWT

Quantity affected

45 USA

Distribution

Nationwide Distribution.

Date initiated

2012-09-04

Date posted

2012-11-06

Date terminated

2014-04-16

Location

Warsaw, IN