Inter-Op Acetabular System Hooded Trial Insert size 32mm/57mm, non-sterile, REF 9363-32-057, Zimmer, Warsaw, IN.

FDA device recall Z-0619-2011 · posted 2010-12-14 · Terminated

Recall details

Recalling firm

Zimmer Inc.

Reason for recall

Mislabeled - Device packages labeled as hooded trial inserts contain standard trial inserts.

Action taken

Zimmer contacted the two affected accounts directly by phone on November 15, 2010 to inform them of the recall. Zimmer will monitor the return of the affected instruments and account for the outstanding instruments until the removal action is complete. Each of the affected accounts will be provided with a new trial insert, manufactured and packaged with the correct component. The accounts will be asked to return the affected units back to Zimmer where the returned product will be destroyed. Customers can contact Zimmer at 574 371-8852 concerning this recall.

Root cause

Employee error

Status

Terminated

Product code

HWT

Quantity affected

3

Distribution

Worldwide Distribution: US in the states of KS and UT, and the country of Canada.

Date initiated

2010-11-15

Date posted

2010-12-14

Date terminated

2011-05-23

Location

Warsaw, IN