Zimmer Trilogy Acetabular System Shell with Cluster Holes, Porous, 60mm O.D., Tivanium TI-6AL-4V Alloy, Hip Prosthesis C
FDA device recall Z-0620-2008 · posted 2008-03-19 · Terminated
Recall details
- Recalling firm
- Zimmer Inc.
- Reason for recall
- Parts missing and incomplete etch: The units may not contain the locking ring or the etched alignment marks on the rim.
- Action taken
- Zimmer sent consignees a Product Recall Notification letter dated 10/19/07, requiring them to return the product.
- Root cause
- Process control
- Status
- Terminated
- Product code
- LPH
- Quantity affected
- 31
- Distribution
- Worldwide Distribution - USA (Arizona, California, Delaware, Indiana, Iowa, Kansas, Massachusetts, New York, Ohio, Pennsylvania, South Carolina, Texas, and Wisconsin), Australia, Canada, Germany, Ital
- Date initiated
- 2007-10-19
- Date posted
- 2008-03-19
- Date terminated
- 2008-05-21
- Location
- Warsaw, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TRILOGY ACETABULAR SYSTEM (K934765) | Zimmer, Inc. | 1994-04-29 |