Recall Z-1095-2011 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Stryker Howmedica Osteonics Corp.
Triathlon Femoral Distal Fixation Peg; Catalog Number 5575-X-00; Manufactured by Stryker Howmedica Osteonics Corp., Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 USA A Subsidiary of Stryker Corp. One single unit to a package. Triathlon Distal Femoral Fixation Pegs are made available separate from the Triathlon Posteriorly Stabilized Femoral Component. These distal femoral fi
| Date | Feb 11, 2011 (initiated Dec 22, 2010) |
| Status | Terminated |
| Reason | Stryker Orthopaedics has become aware that the labels on the Triathlon Distal Femoral Fixation Pegs contain an incorrect expiration date of January 2015 (2015-1) when the actual expiration date should read June 2014 (2014-6). |
| Root cause | Incorrect or no expiration date |
| Action | The firm, Stryker, sent a "UPDATED (Corrected Lot Code) URGENT PRODUCT RECALL" letter dated January 6, 2011, via Fed Ex ,with return receipt to all customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed to fax the attached Product Recall Acknowledgement form to (201) 831-6069; contact the hospitals in their territory that have the affected product to arrange return of the product, and return the affected product to the attention of Regulatory Compliance, Stryker Orthopaedics, 325 Corporate Drive Mahwah, NJ 07430. If you h |
| Quantity | 15 units |
| Distribution | Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031729 | TRIATHLON POSTERIORLY STABILIZED (PS) TOTAL KNEE SYSTEM Howmedica Osteonics Corp., Sep 2, 2003 |