Device Recall Triathlon PKR Insert X3 1

8 mm - LM/RL Catalog number 5630-G-108, Lot code NXDMEE; 12 mm -RM/LL Catalog number 5630-G-122 Lot code M8JMEE.

Orthopedic Devices

2

Yes

Nationwide distribution: Product was distributed to 7 Stryker branches and one hospital.

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 unicompartmental knee prosthesis || - As an alternative to tibial osteotomy in patients with unicompartmental || osteoarthritis, where bone stock is of poor quality or inadequate for other || reconstructive techniques as indicted by deficiencies of the femoral || condyle/tibia plateau. || These components are intended for implantation with bone cement. || Stryker Orthopaedics; || Howmedica Osteonics Copr. || 325 Corporate Drive || Mahwah, NJ 07430