—#76807

Product

Triathlon X3 Posterior Stabilized Tibial Insert Use with Triathlon PS Femoral Components. Sze 7, THKNS 13 m and SZE 8, THKNS 13mm; Catalog number 5532-G-713, Catalog number 5532-G-813 Stryker Orthopaedics

FDA product code: JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K051146
Affected lot / code info: Lot code LBD528 and Lot code LBD512.

Why it was recalled

Stryker Orthopaedics became aware of a lot for lot mix-up between part numbers 5532-G-713, lot code LBD528 (Triathlon X3 Posterior Stabilized Tibial Insert, size 7-13 mm) and part 5532-G-813, lot code LBD512 (Triathlon X3 Posterior Stabilized Tibial Insert Size 8-13 mm)

Root cause (FDA determination)

Labeling mix-ups

Action the firm took

Urgent Product Recall letters were sent via Federal Express on December 18, 2008 with return receipt to Stryker branches, Hospital Risk Management, Hospital Chief of Orthopaedics and Surgeons. The letter stated the issue, the potential hazards, and the risk mitigation factors. The firm asked customers to examine their inventory and hospital locations to identify affected product; retrieve all affected product and return it to their branch or agency warehouse for reconciliation; reconcile all products on the attached Product Accountability Form; and return affected product. Questions should be directed to Karen Ariemma at 201-831-5718.

Recalling firm

Firm: Stryker Howmedica Osteonics Corp.
Address: 325 Corporate Dr, Mahwah, New Jersey 07430

Distribution

Distribution pattern: Nationwide Distribution: FL and IL.

Timeline

Recall initiated: 2008-12-18
Posted by FDA: 2009-03-03
Terminated: 2012-09-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #76807. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.