TUNNELOC ROUND HEAD INTERFERENCE SCREW 8MMX25MM Biomet Sports… — Class II medical device recall Z-0753-2013
Terminated recall by Biomet, Inc., reported 2013-02-06, distributed in AL, CA, FL, IL, KY, OH, TX. Thru hole at the tip of the screw is undersized.
| Recall number | Z-0753-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2013-01-03 |
| Classified | 2013-01-30 |
| Reported by FDA | 2013-02-06 |
| Terminated | 2013-08-02 |
| Distributed | AL, CA, FL, IL, KY, OH, TX |
| Countries outside the US | AU, CL, MX, NL |
| Quantity | 44 units |
| Model numbers | 909668 |
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 for recall
Thru hole at the tip of the screw is undersized.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0753-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.