Class 2 Device Recall Biomet OSS Interlok IM Stem w/Screw

• Date Initiated by Firm: May 15, 2008
• Date Posted: September 11, 2008
• Recall Status: Terminated on November 03, 2008
• Recall Number: Z-1881-2008
• Recall Event ID: 48633
• 510(K)Number: K002757
• Product Classification: Knee joint femorotibial metal/polymer constrained cemented prosthesis - Product Code KRO
• Product: Biomet OSS Interlok IM Stem w/Screw, straight collar, 15 mm x 225 mm, TI6AL4V alloy, sterile, Biomet Orthopedics, Inc., Warsaw, IN; REF 150492. Orthopedic implant intended as part of a replacement knee joint.
• Code Information: Lots 354060 and 138050.
• Recalling Firm/ Manufacturer: Biomet, Inc.; 56 E Bell Dr; Warsaw IN 46582
• For Additional Information Contact: 800-348-9500
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Labeling False and Misleading
• Action: 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.
• Quantity in Commerce: 14 for all products.
• Distribution: Class II Recall - Nationwide Distribution --- including states of California, Indiana, Kentucky, Massachusetts and Virginia.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = KRO