Recall Z-0579-2009 ยท MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Stryker Howmedica Osteonics Corp.
Triathlon Total Knee system Primary Tibial Baseplate #5 Beaded wPA; Catalog Number 5526-B-500, Cementless use only. Sterile. Howmedica Osteonics, 325 Corporate Drive, Mahwah, NJ 07430; A subsidiary of Stryker Corp. Made in Ireland. The Triathlon Total Knee System is intended for use in primary and revision total knee arthroplasty to alleviate pain and restore function.
| Date | Jan 8, 2009 (initiated Sep 21, 2006) |
| Status | Terminated |
| Reason | Stryker Orthopaedics became aware that one lot of the Triathlon Primary Beaded PA Baseplate Size 5 may not have the Peri-Apatite coating. |
| Root cause | Process change control |
| Action | Important Market Withdrawal notification letters were sent via Fed Ex on 9/20/06 to the direct accounts. Notification letters informed of the reason for the market withdrawal and requested that all branches examine their inventory and hospital consignment locations to identify the product. Product was to be reconciled on the Product Accountability Form and returned to Stryker as per instructions. Contact Stryker Howmedica Osteonics Corp at 1-201-831-5718 for assistance. |
| Quantity | 10 |
| Distribution | PA, GA, AL, WI, UT, and OR. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051380 | TRIATHLON PRESS-FIT TOTAL KNEE SYSTEM Howmedica Osteonics Corp., Aug 30, 2005 |