Class 2 Device Recall Triathlon PKR Insert X3 1

• Date Initiated by Firm: November 25, 2008
• Date Posted: January 12, 2009
• Recall Status: Terminated on August 30, 2010
• Recall Number: Z-0869-2009
• Recall Event ID: 50535
• 510(K)Number: K071881
• Product Classification: Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis - Product Code HRY
• Product: 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
• Code Information: 8 mm - LM/RL Catalog number 5630-G-108, Lot code NXDMEE; 12 mm -RM/LL Catalog number 5630-G-122 Lot code M8JMEE.
• Recalling Firm/ Manufacturer: Stryker Howmedica Osteonics Corp.; 325 Corporate Dr; Mahwah NJ 07430
• For Additional Information Contact: Karen Ariemma, RAC; 201-831-5718
• Manufacturer Reason for Recall: 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.
• FDA Determined 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 in Commerce: 8 mm - 1 unit; 12 mm - 8 units.
• Distribution: Nationwide distribution: Product was distributed to 7 Stryker branches and one hospital.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = HRY