STA-Flex SUBTALAR SCREW, 7 mm x 13 mm, REF 982361, Sterile, Biomet Sports Medicine, 56 East Bell Drive, Warsaw, IN. Used

FDA device recall Z-1612-2011 · posted 2011-03-09 · Terminated

Recall details

Recalling firm

Biomet, Inc.

Reason for recall

The firm has initiated this recall following internal fatigue testing that shows possible initiation of fatigue cracking in implants under load.

Action taken

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.

Root cause

Pending

Status

Terminated

Product code

HWC

Quantity affected

254 units all products

Distribution

Nationwide Distribution.

Date initiated

2011-01-21

Date posted

2011-03-09

Date terminated

2011-11-10

Location

Warsaw, IN

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