Recalls / —

—#95807

Product

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

FDA product code

HWT — Template

Device class

Class 1

Medical specialty

Orthopedic

Affected lot / code info

61438482

Why it was recalled

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

Root cause (FDA determination)

Employee error

Action the firm took

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.

Recalling firm

Firm

Zimmer Inc.

Address

1800 W Center St, Warsaw, Indiana 46580-2304

Distribution

Distribution pattern

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

Timeline

Recall initiated

2010-11-15

Posted by FDA

2010-12-14

Terminated

2011-05-23

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #95807. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.