Device product
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 intended for use in fixation of patellar bone-tendon-bone grafts in ACL reconstruction.
Z-0753-2013
Product summary
- Firm
- Biomet, Inc.
- Event
- Event 64004
- Status
- Terminated
- Classification
- Class II
- Quantity
- 44 units distributed
- Official record key
device-enforcement:Z-0753-2013
Official wording
Reason: Thru hole at the tip of the screw is undersized.
Code information: Catalog Number: 909668 Lot Number Identification: 716710
Distribution pattern: Worldwide Distribution - USA including CA, FL, IL, AL, OH, KY, TX , and Internationally to Australia, Columbia, Mexico, Netherlands, and Chile.
Derived failure modes
-
Unknown
Thru hole at the tip of the screw is undersized.