Class 2 Device Recall STAFlex SUBTALAR SCREW

• Date Initiated by Firm: January 21, 2011
• Date Posted: March 09, 2011
• Recall Status: Terminated on November 10, 2011
• Recall Number: Z-1615-2011
• Recall Event ID: 57831
• 510(K)Number: K071498
• Product Classification: Bone Fixation Screw - Product Code HWC
• Product: STA-Flex SUBTALAR SCREW, 10 mm x 16 mm, REF 982364, 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: 384950, 879290, and 890870.
• Recalling Firm/ Manufacturer: Biomet, Inc.; 56 E Bell Dr; Warsaw IN 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: Pending
• 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 all products
• Distribution: Nationwide Distribution.
• 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