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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 Recall
Arthrotek Interference Screw
see related information
Date Posted January 30, 2013
Recall Status1 Terminated on August 02, 2013
Recall Number Z-0753-2013
Recall Event ID 64004
Premarket Notification
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, Indiana 46582-6989
Consumer Instructions Contact the recalling firm for information
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
PRODUCTION CONTROLS: 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 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, INC.
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