Recall Z-0620-2008 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Zimmer Inc.
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.
| Date | Mar 19, 2008 (initiated Oct 19, 2007) |
| Status | Terminated |
| Reason | Parts missing and incomplete etch: The units may not contain the locking ring or the etched alignment marks on the rim. |
| Root cause | Process control |
| Action | Zimmer sent consignees a Product Recall Notification letter dated 10/19/07, requiring them to return the product. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K934765 | TRILOGY ACETABULAR SYSTEM Zimmer, Inc., Apr 29, 1994 |