FDA Device recall Z-0753-2013
TUNNELOC ROUND HEAD INTERFERENCE SCREW 8MMX25MM Biomet Sports Medicine manufactures a variety of internal fixation devices intended to aid…
- FDA Device
- Class II
- terminated
- Published 2013-02-06
On 2013-02-06 the FDA classified a Class II recall of TUNNELOC ROUND HEAD INTERFERENCE SCREW 8MMX25MM Biomet Sports Medicine manufactures a variety of internal fixation devices intended to aid… by Biomet, citing thru hole at the tip of the screw is undersized.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0753-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-01-03 |
| Published | 2013-02-06 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Biomet |
| Distribution | AL, CA, FL, IL, KY, OH, TX |
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.
Reason
Thru hole at the tip of the screw is undersized.
Identifiers
| code_info | Catalog Number: 909668 Lot Number Identification: 716710 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0753-2013%22
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