Ti-Magna Fx Washer Ti-Versa-FXII Femoral Fixation System S/C Plates The compression tube/plates of this trauma system ar

FDA device recall Z-0129-2014 · posted 2013-11-01 · Terminated

Recall details

Recalling firm

Zimmer, Inc.

Reason for recall

Zimmer recently conducted a review of historic packaging validations completed. Based on this review, it was determined that a subset of product packaged at a single Zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity. The number of samples required for packaging testing, to provide statisti

Action taken

The firm, Zimmer Inc., sent a letter entitled "Voluntary Recall of Ti-VFxII Condylar Tube Plates and Ti-Washers" dated September 12, 2013 to its customer. The letter described the product, problem and action to be taken. The customer was instructed to immediately discontinue use of the listed products. A Sales representatives from Zimmer K.K. or agencies will be in contact with you. Zimmer Inc. is planning to resume product manufacturing upon the completion of package validation review. Zimmer K.K. will contact you when a detailed schedule has been determined. If you have any questions, contact Zimmer K.K. Safety Office (9:00 to 17:00; closed weekends and public holidays) TEL: 0120-015-180.

Root cause

Packaging process control

Status

Terminated

Product code

NDG

Quantity affected

2,632 devices

Distribution

International distribution: Japan only.

Date initiated

2013-08-28

Date posted

2013-11-01

Date terminated

2015-04-30

Location

Warsaw, IN