CoCr Head (Not distributed in the United States) Used in total hip replacement.

FDA device recall Z-0072-2014 · posted 2013-10-25 · Terminated

Recall details

Recalling firm

Zimmer, Inc.

Reason for recall

The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.

Action taken

August 30, 2013 Urgent Recall Notices were sent to Distributors, hospital risk managers and surgeons identifying the issue and directing consignees to make all affected personnel aware of the contents of the notification. The notice identified the products involved, the issue, possible adverse events associated with the issue and recommended that implants found with LDPE bag adhesion not use the product and return it to Zimmer sales representatives. Questions or concerns should be addressed to Zimmer customer call center at 1-877-946-2761 between the hours of 8 a.m. and 5 p.m. EST.

Root cause

Package design/selection

Status

Terminated

Product code

LPH

Quantity affected

604064 total

Distribution

Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Germany, Guatemal

Date initiated

2013-08-30

Date posted

2013-10-25

Date terminated

2014-09-25

Location

Warsaw, IN