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U.S. Department of Health and Human Services

Class 2 Device Recall Biomet 5.5mm peek allthread, knotless,

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 Class 2 Recall
Biomet 5.5mm peek allthread, knotless,
see related information
Date Posted November 12, 2009
Recall Status1 Terminated on January 19, 2011
Recall Number Z-0191-2010
Recall Event ID 53581
Premarket Notification
510(K) Number
K070389 
Product Classification Screw, Fixation, Bone - Product Code HWC
Product Biomet 5.5 mm peek Allthread PEEK Knotless Anchor, knotless, sterile, Biomet sports Medicine, Inc., Ontario, CA; REF 904842P. Intended to be implanted for fixation of bone fractures and for bone reconstructions.
Code Information All lots. Lot Numbers: 006120, 006130, 006150, 310980, 457500, 457510, 457520, 528050, 549180, 597000, 597010, 689520, 689530, 689540, 843100, 843140, 933310 and 933320.
Recalling Firm/
Manufacturer
Biomet, Inc.
56 E Bell Dr
Warsaw, Indiana 46582
Manufacturer Reason
for Recall
These anchors may be difficult to remove, or may not detach from the inserter shaft.
FDA Determined
Cause 2
DESIGN: Device Design
Action Biomet issued an "Urgent Medical Device Recall Notice" dated September 9, 2009 informing consignees of the affected product and requesting return of the device. Distributors were instructed to notify their customers copy of the recall letter and to locate and return the products from user facilities. For further information, contact Biomet at 1-800-348-9500 or 1-574-372-3983.
Quantity in Commerce 894
Distribution Worldwide Distribution -- United States and Belgium.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = HWC and Original Applicant = BIOMET SPORTS MEDICINE, INC.
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