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Terminated

Versys Hip System femoral stem, fiber metal midcoat, collared, 12/14 neck taper, low head center, size 14, standard body. Cat. No. 7841-14-10.

FDA Recall Z-0475-03 · Posted 2003-01-28

Recalling FirmZimmer Inc.
Recall StatusTerminated
Product CodeLPH
Date Initiated2003-01-07
Date Terminated2004-02-09

Reason for Recall

The femoral heads will not seat onto the taper of the hip stem, as the head impinges on the radius undercut below the taper.

Firm Action

Recall letters dated 1/7/03 were sent to each U.S. consignee via certified mail, requesting that they contact Zimmer for pick-up of the products if any was in stock. Ex-U.S. consignees were notified via e-mail.

Root Cause

Other

Distribution Pattern

United States, Australia and Canada.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K922071ZIMMER ANATOMIC HIP SYSTEMZimmer, Inc. · 1994-02-22

Official Source

View FDA Recall →

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

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