Recall Z-1615-2011 ยท HWC Screw, Fixation, Bone
Biomet, Inc.
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.
| Date | Mar 9, 2011 (initiated Jan 21, 2011) |
| Status | Terminated |
| Reason | The firm has initiated this recall following internal fatigue testing that shows possible initiation of fatigue cracking in implants under load. |
| Root 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 pati |
| Quantity | 254 all products |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071498 | SUBTALAR IMPLANT Biomet Sports Medicine, Inc., Jul 31, 2007 |