—#79247

Product

Zimmer, Insall/Burstein II Modular Knee System, Tibial Wedge and 2 Screws, Size 59, 7 Deg. x 9.5 mm Height, Tivanium TI-6AL-4V Alloy, sterile; REF 5220-62-01.

FDA product code: HSX — Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K862632
Affected lot / code info: Lot 07878240.

Why it was recalled

Smaller diameter screws than required were included in the package.

Root cause (FDA determination)

Process control

Action the firm took

Zimmer notified consignees by recall letter dated 2/25/09 instructing them to cease use of the device and to return it. Zimmer distributors and international accounts were notified by email on 2/26/09.

Recalling firm

Firm: Zimmer Inc.
Address: 345 E Main St, Warsaw, Indiana 46580-2746

Distribution

Distribution pattern: USA (Connecticut, Indiana, Pennsylvania), Australia, Serbia, Spain, Switzerland and the United Kingdom.

Timeline

Recall initiated: 2009-02-26
Posted by FDA: 2009-12-22
Terminated: 2011-02-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #79247. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.