Trilogy II Constrained Liner The Trilogy Longevity Constrained Liner serves as the articular surface for a femoral head
FDA device recall Z-0386-2013 · posted 2012-11-20 · Terminated
Recall details
- Recalling firm
- Zimmer, Inc.
- Reason for recall
- Trilogy Longevity Constrained Liner devices were packaged in incorrect cartons. The product is packaged in the incorrect carton. Product labels and patient labels are correct, matching the product inside the carton.
- Action taken
- Zimmer contacted their customer beginning the week of August 27, 2012, via telephone. Zimmer informed the customer the reason of the recall. The customer was instructed to quarantine and return the device to Zimmer Product Service, 1777 W. Center St. Warsaw, IN 46580. The customer was asked to provide information if the product was further distributed. For further questions please call 574-372-4316.
- Root cause
- Labeling Change Control
- Status
- Terminated
- Product code
- KWZ
- Quantity affected
- 1
- Distribution
- USA (nationwide) including the states of Ohio, Carolinas and New England.
- Date initiated
- 2012-08-27
- Date posted
- 2012-11-20
- Date terminated
- 2013-08-27
- 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 LONGEVITY CONSTRAINED LINER (K071718) | Zimmer, Inc. | 2007-07-13 |