—#66186

Product

OSS (Orthopedic Salvage System) RS Non-Modular Long Tibial Base, Porous Coated, 71mm x 10 x 160mm, Co-CR-MO/Ti-6AL-4V alloy, sterile; Part 161043. Implant is part of a system used to replace the tibial portion of the knee joint.

FDA product code: KRO — Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K052685
Affected lot / code info: Lots 053850, Exp 08/2016; 070890, Exp 08/2016; 201930, Exp 09/2016; 364790, Exp 10/2016; 507290, Exp 11/2016 and 534910, Exp 04/2017.

Why it was recalled

Mislabeled as to size: Product is labeled as reduced size, but is actually standard size.

Root cause (FDA determination)

Labeling mix-ups

Action the firm took

Consignees were notified by an Urgent Medical Device Recall Notice letter dated 11/7/07. The letter required that use of the product be immediately discontinued and that components be returned to Biomet. Letters to hospital administrators and the five implanting surgeons were issued on/or about 5/6/08 advising them of the problem and to perform patient evaluations.

Recalling firm

Firm: Biomet, Inc.
Address: 56 E Bell Dr, Warsaw, Indiana 46581-0587

Distribution

Distribution pattern: Nationwide Distribution --- including states of California, Florida, Illinois, Indiana, Massachusetts, Missouri, New Jersey, Oklahoma, Pennsylvania, Texas, Virginia and Washington.

Timeline

Recall initiated: 2007-11-07
Posted by FDA: 2008-09-17
Terminated: 2009-03-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #66186. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.