Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0620-2008

Zimmer Trilogy Acetabular System Shell with Cluster Holes, Porous, 60mm O.D., Tivanium TI-6AL-4V Alloy, Hip...

Zimmer GmbH / initiated 2007-10-19 / Terminated / root cause: manufacturing process

Zimmer Inc. began a recall of Zimmer Trilogy Acetabular System Shell with Cluster Holes, Porous, 60mm O.D., Tivanium TI-6AL-4V Alloy, Hip Prosthesis Component, REF 6200-060-22, Catalog #... on . The reason FDA records is "Parts missing and incomplete etch: The units may not contain the locking ring or the etched alignment marks on the rim". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-0620-2008
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Zimmer GmbH
Product
Zimmer Trilogy Acetabular System Shell with Cluster Holes, Porous, 60mm O.D., Tivanium TI-6AL-4V Alloy, Hip Prosthesis Component, REF 6200-060-22, Catalog # 00-6200-060-22, Zimmer, Inc., Warsaw, IN, 46580.
Product code
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Reason for recall
Parts missing and incomplete etch: The units may not contain the locking ring or the etched alignment marks on the rim.
Root cause tag
manufacturing process
FDA root cause
Process control
Action
Zimmer sent consignees a Product Recall Notification letter dated 10/19/07, requiring them to return the product.
Quantity in commerce
31
Distribution
Worldwide Distribution - USA (Arizona, California, Delaware, Indiana, Iowa, Kansas, Massachusetts, New York, Ohio, Pennsylvania, South Carolina, Texas, and Wisconsin), Australia, Canada, Germany, Italy, and Spain.
Product codes and lots
Lot Number: 26208600; exp. 2013-02.