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Terminated

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

FDA Recall Z-0539-05 · Posted 2005-02-15

Recalling FirmZimmer Austin, Inc
Recall StatusTerminated
Product CodeKRO
Date Initiated2004-12-17
Date Terminated2007-11-27
Product Quantity121 units

Reason for Recall

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

Firm Action

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

Root Cause

Other

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K013031MOST OPTIONS SYSTEMSulzer Orthopedics, Inc. · 2001-12-07

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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