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.
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