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.
Reported: February 6, 2013 Initiated: January 3, 2013 #Z-0753-2013
Product Description
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.
Reason for Recall
Thru hole at the tip of the screw is undersized.
Details
- Recalling Firm
- Biomet, Inc.
- Units Affected
- 44 units distributed
- Distribution
- Worldwide Distribution - USA including CA, FL, IL, AL, OH, KY, TX , and Internationally to Australia, Columbia, Mexico, Netherlands, and Chile.
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Biomet, Inc.. Units affected: 44 units distributed.
Why was this product recalled? ▼
Thru hole at the tip of the screw is undersized.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 6, 2013. Severity: Moderate. Recall number: Z-0753-2013.
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