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U.S. Department of Health and Human Services

Class 2 Device Recall Arthrotek Interference Screw

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  Class 2 Device Recall Arthrotek Interference Screw see related information
Date Initiated by Firm January 03, 2013
Date Posted January 30, 2013
Recall Status1 Terminated 3 on August 02, 2013
Recall Number Z-0753-2013
Recall Event ID 64004
510(K)Number K934469  
Product Classification Screw, fixation, bone - Product Code HWC
Product TUNNELOC ROUND HEAD INTERFERENCE SCREW
8MMX25MM
Biomet Sports Medicine manufactures a variety of internal fixation devices intended to aid in arthroscopic and orthopedic reconstructive procedures requiring soft tissue fixation, due to injury or degenerative disease. Implants used for this application include: screws, washers, anchors, pins, and suture. Interference Screws and Set Screws are intended for use in fixation of patellar bone-tendon-bone grafts in ACL reconstruction.
Code Information Catalog Number: 909668 Lot Number Identification: 716710
Recalling Firm/
Manufacturer		 Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact Craig Buchman
574-267-6639 Ext. 1676
Manufacturer Reason
for Recall		 Thru hole at the tip of the screw is undersized.
FDA Determined
Cause 2		 Reprocessing Controls
Action Biomet sent an URGENT MEDICAL DEVICE RECALL letter dated January 3, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed locate and discontinue use of the affected product and return it to Biomet. recall notification was sent to all consignees on 1/4/2013. The action requires the immediate location and discontinued use of the product and its return to Biomet. Questions related to this notice should be directed to (574) 372-1570, Monday through Friday, 8a.m. to 5 p.m. For questions regarding this recall call 574-267-6639, ext 1676.
Quantity in Commerce 44 units distributed
Distribution Worldwide Distribution - USA including CA, FL, IL, AL, OH, KY, TX , and Internationally to Australia, Columbia, Mexico, Netherlands, and Chile.
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, INC.
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