Free Lock Femoral Hip Fixation System Compression Lag Screw . Several lengths (55 to 150 mm) and diameters (12.7 and 15.

FDA device recall Z-2090-2013 · posted 2013-08-26 · Terminated

Recall details

Recalling firm

Zimmer, Inc.

Reason for recall

Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak test compromising the sterility of the product.

Action taken

The firm, Zimmer, sent an "URGENT MEDICAL DEVICE NOTIFICATION" letter dated July 11, 2013 to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to inspect the device according to the insert instructions; not use the device if damage to the corner of the inner tray is observed, and contact the firm for return and questions. Customers should also keep this notification in mind and inform Zimmer of product with this condition using zimmer.per@zimmer.com. If after reviewing this notification you have questions or concerns, please contact Zimmer at 1-877-946-2761.

Root cause

Packaging process control

Status

Terminated

Product code

KTT

Quantity affected

85, 794 units in total

Distribution

Worldwide distribution: US Nationwide (including PR and USVI), and countries of: Israel, Argentina, Brazil, France, Mexico, Saudi Arabia, Beirut, China, Korea, San Salvador, Honduras, Canada, Australi

Date initiated

2013-06-19

Date posted

2013-08-26

Date terminated

2015-06-16

Location

Warsaw, IN

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