Recall Z-0869-2009 ยท HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
Stryker Howmedica Osteonics Corp.
Triathlon PKR Insert X3 #1 LM/RL - 8mm, 5630-G-108, Lot code NXDMEE Triathlon PKR Insert X3 #1 RM/LL - 12mm, 5630-G-122, Lot Code M8JMEE Intended Use: - Moderately disabling joint disease of the knee resulting from painful osteo- or post traumatic arthritis - Revision of previous unsuccessful surgical procedures, either involving, or not involving, previous use of a unico
| Date | Jan 12, 2009 (initiated Nov 25, 2008) |
| Status | Terminated |
| Reason | Label mix-up: Stryker Orthopaedics became aware of a lot for lot mix up between Triathlon PKR Insert X3 #1 LM/RL 8mm, 5630-G-108 lot code NXDMEE and Triathlon PKR Insert X3 #1 RM/LL- 12 mm 5630-G-122 lot code M8JMEE. |
| Root cause | Labeling mix-ups |
| Action | Recall notifications entitled "URGENT PRODUCT RECALL" were sent via Federal Express on 11/25/2008 to Stryker branches, hospital risk management, Hospital Chief of Orthopaedics. For further information, please contact Stryker Howmedica Osteonics Corporation by telephone at 201-831-5718. |
| Quantity | 8 mm - 1 unit; 12 mm - 8 units. |
| Distribution | Nationwide distribution: Product was distributed to 7 Stryker branches and one hospital. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071881 | TRIATHLON PKR SYSTEM Howmedica Osteonics Corp., Oct 9, 2007 |