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U.S. Department of Health and Human Services

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

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 Class 2 Device Recall Biomet OSS Interlok IM Stem w/Screwsee related information
Date Initiated by FirmMay 15, 2008
Date PostedSeptember 11, 2008
Recall Status1 Terminated 3 on November 03, 2008
Recall NumberZ-1880-2008
Recall Event ID 48633
510(K)NumberK002757 
Product Classification Knee joint femorotibial metal/polymer constrained cemented prosthesis - Product Code KRO
ProductBiomet 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.
Code Information Lots 354050, 138040 and 067490.
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 2
Labeling False and Misleading
ActionOn 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 Commerce14 for all products.
DistributionClass II Recall - Nationwide Distribution --- including states of California, Indiana, Kentucky, Massachusetts and Virginia.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = KRO
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