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.
FDA Recall Z-0753-2013 · Posted 2013-01-30
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Recalling FirmBiomet, Inc.
Recall StatusTerminated
Product CodeHWC
Date Initiated2013-01-03
Date Terminated2013-08-02
Product Quantity44 units distributed
Reason for Recall
Thru hole at the tip of the screw is undersized.
Firm 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 this recall call 574-267-6639, ext 1676.
Root Cause
Reprocessing Controls
Distribution Pattern
Worldwide Distribution - USA including CA, FL, IL, AL, OH, KY, TX , and Internationally to Australia, Columbia, Mexico, Netherlands, and Chile.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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