Multipolar Bipolar Cup METAL SHELL 38 MM OD through 71 MM OD. Indicated in fracture dislocation of the hip.

FDA device recall Z-0068-2014 · 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

KWY

Quantity affected

72806

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

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