Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0472-03

Versys Hip System femoral stem, fiber metal midcoat, collared, 12/14 neck taper, low head center, size 11...

Zimmer GmbH / initiated 2003-01-07 / Terminated

Zimmer Inc. began a recall of Versys Hip System femoral stem, fiber metal midcoat, collared, 12/14 neck taper, low head center, size 11, standard body. Cat. No. on . The reason FDA records is "The femoral heads will not seat onto the taper of the hip stem, as the head impinges on the radius undercut below the taper". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0472-03
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Zimmer GmbH
Product
Versys Hip System femoral stem, fiber metal midcoat, collared, 12/14 neck taper, low head center, size 11, standard body. Cat. No. 7841-11-10.
Product code
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
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.
FDA root cause
Other
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.
Distribution
United States, Australia and Canada.
Product codes and lots
All lots.