—#71766

Product

Biomet OSS Interlok IM Stem w/Screw, straight collar, 13 mm x 225 mm, TI6AL4V alloy, sterile, Biomet Orthopedics, Inc., Warsaw, IN; REF 150491. Orthopedic implant intended as part of a replacement knee joint.

FDA product code: KRO — Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K002757
Affected lot / code info: Lots 354050, 138040 and 067490.

Why it was recalled

Mislabeled--The product is not collared, although the label states that it is collared. A non-collared component will provide a reduced contact with bone interface and/or a delay in the procedure may be incurred while clarifying package contents.

Root cause (FDA determination)

Labeling False and Misleading

Action the firm took

On May 15, 2008 an Urgent Medical Device Removal Notice was issued to consignees and implanting physicians notifying them to return the product and of risks involved, respectively. Any adverse reactions which may be experienced with the use of this product should be reported to FDA's MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852, or the MedWatch website at www.fda.gov/medwatch. If you have any questions contact Mary Hardesty, Manager, Corrective Actions, Biomet Orthopedics, Inc. at 1-800-348-9500.

Recalling firm

Firm: Biomet, Inc.
Address: 56 E Bell Dr, Warsaw, Indiana 46582

Distribution

Distribution pattern: Class II Recall - Nationwide Distribution --- including states of California, Indiana, Kentucky, Massachusetts and Virginia.

Timeline

Recall initiated: 2008-05-15
Posted by FDA: 2008-09-11
Terminated: 2008-11-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #71766. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.