FDA Recall Terminated

MOST Options System Porous and Non-Porous Revision Stem Adapters, manufactured and distributed by Zimmer Austin, Inc., Austin, Texas 78717

Recall: Z-0539-05 · Initiated December 17, 2004

Recall

Recall Number
Z-0539-05
Event Number
30720
Firm
Zimmer Austin, Inc
FEI Number
2935620
Product Code
KRO
Status
Terminated
Root Cause
Other
Initiated
December 17, 2004
Posted
February 15, 2005
Terminated
November 27, 2007
Address
9900 Spectrum Dr, Austin, TX, 78717-4555

Description

MOST Options System Porous and Non-Porous Revision Stem Adapters, manufactured and distributed by Zimmer Austin, Inc., Austin, Texas 78717

Reason

Risk of adapter disassociation from mating components when assembled improperly or when subjected to high-stress femoral applications.

Action

The firm initiated the recall via letter on December 17, 2004. The firm''s letter requests the return of all recalled product.

Distribution

The product was distributed in AZ, CA, NY, IL, FL, MD, OH, MI, WI, MO, TX and to Canada and Portugal

Quantity

121 units