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U.S. Department of Health and Human Services

Class 2 Device Recall STAFlex SUBTALAR SCREW

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 Class 2 Recall
STAFlex SUBTALAR SCREW
see related information
Date Posted March 09, 2011
Recall Status1 Terminated on November 10, 2011
Recall Number Z-1612-2011
Recall Event ID 57831
Premarket Notification
510(K) Number
K071498 
Product Classification Screw, Fixation, Bone - Product Code HWC
Product STA-Flex SUBTALAR SCREW, 7 mm x 13 mm, REF 982361, Sterile, Biomet Sports Medicine, 56 East Bell Drive, Warsaw, IN. Used to reduce excessive rearfoot pronation by blocking forward and downward displacement of the Talus, resulting in improved rearfoot alignment and foot function.
Code Information Lot Numbers: 890840 and 918570.
Recalling Firm/
Manufacturer
Biomet, Inc.
56 E Bell Dr
Warsaw, Indiana 46582
For Additional Information Contact Mary Johnson
574-267-6639 Ext. 1676
Manufacturer Reason
for Recall
The firm has initiated this recall following internal fatigue testing that shows possible initiation of fatigue cracking in implants under load.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Under Investigation by the firm
Action The firm sent URGENT MEDICAL DEVICE RECALL NOTICES dated 1/21/2011 to distributors, implanting physicians, and medical facilities. The letter to the distributors and medical facilities states the recalled product should be immediately located and returned to Biomet. In addition, the "FAX Back Response Form" should be completed and returned to the number provided. If product has been further distributed, distributors are to contact hospital personnel via the enclosed "Dear Biomet Customer" notice. The letter to the implanting physicians informs the physician of the recall and lists the patients that were implanted with the device. The physician letter quotes from the surgical technique "the implant should also be removed if any postoperative complications occur". The letter to the implanting physicians does not recommend any action be taken with the devices that are implanted. The notice just makes the surgeons aware of the recall. Distributors and Physicians are to confirm receipt of the letter by contacting 800-348-9500, ext 3755 or 3756. Also, questions related to this matter should be directed to 574-371-3755 or 574-371-3756.
Quantity in Commerce 254 units all products
Distribution Nationwide Distribution.
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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