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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 Device Recall Biomet 5.5mm peek allthread, knotless, see related information
Date Initiated by Firm September 09, 2009
Date Posted November 12, 2009
Recall Status1 Terminated 3 on January 19, 2011
Recall Number Z-0191-2010
Recall Event ID 53581
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 IN 46582
For Additional Information Contact
800-348-9500
Manufacturer Reason
for Recall		 These anchors may be difficult to remove, or may not detach from the inserter shaft.
FDA Determined
Cause 2		 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 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 = HWC and Original Applicant = BIOMET SPORTS MEDICINE, INC.
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