Recall Z-0386-2013 ยท KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
Zimmer, Inc.
Trilogy II Constrained Liner The Trilogy Longevity Constrained Liner serves as the articular surface for a femoral head in total hip arthroplasty.
| Date | Nov 20, 2012 (initiated Aug 27, 2012) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Labeling Change Control |
| Action | 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. |
| Quantity | 1 |
| Distribution | USA (nationwide) including the states of Ohio, Carolinas and New England. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071718 | TRILOGY LONGEVITY CONSTRAINED LINER Zimmer, Inc., Jul 13, 2007 |