—#49780

Product

Triathlon X3 CR Tibial Bearing Insert for knee prosthesis Size #2 - 11MM Ref # 5530-G-211 2011-09 Howmedica Osteonics Corp.

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: Ref. No. 5530-G-211 Lot code G9XF6 LAF974

Why it was recalled

A product mix-up in which the labeling indicates a Triathlon X# CR Tibial Bearing Insert Size #2 - 11MM, however, the device inside the package is actually a Triathlon X3 CR Tibial Bearing insert Size # 7 - 11MM and vice versa.

Root cause (FDA determination)

Other

Action the firm took

Notification letters and Product Accountability forms were sent on 12/8/2006 by Federal Express with return receipt.

Recalling firm

Firm: Stryker Howmedica Osteonics Corp.
Address: 325 Corporate Dr, Mahwah, New Jersey 07430-2002

Distribution

Distribution pattern: Nationwide and Canada.

Timeline

Recall initiated: 2006-12-04
Posted by FDA: 2007-02-08
Terminated: 2007-02-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #49780. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.