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.
FDA Recall Z-0620-2008 · Posted 2008-03-19
Recalling FirmZimmer Inc.
Recall StatusTerminated
Product CodeLPH
Date Initiated2007-10-19
Date Terminated2008-05-21
Product Quantity31
Reason for Recall
Parts missing and incomplete etch: The units may not contain the locking ring or the etched alignment marks on the rim.
Firm Action
Zimmer sent consignees a Product Recall Notification letter dated 10/19/07, requiring them to return the product.
Root Cause
Process control
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.