Recall Z-0753-2013 ยท HWC Screw, Fixation, Bone
Biomet, Inc.
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 intend
| Date | Jan 30, 2013 (initiated Jan 3, 2013) |
| Status | Terminated |
| Reason | Thru hole at the tip of the screw is undersized. |
| Root cause | 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 th |
| Quantity | 44 units distributed |
| Distribution | Worldwide Distribution - USA including CA, FL, IL, AL, OH, KY, TX , and Internationally to Australia, Columbia, Mexico, Netherlands, and Chile. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K934469 | ARTHROTEK INTERFERENCE SCREW Biomet, Inc., Feb 23, 1994 |