Z-0753-2013 Class II Terminated
FDA device recall Z-0753-2013 was initiated by Biomet, Inc. on Jan 3, 2013 and is designated Class II. Reason for recall: Thru hole at the tip of the screw is undersized. The recall status is terminated (terminated Aug 2, 2013). Affected quantity: 44 units distributed.
Recall Details
- Product Type
- Devices
- Report Date
- Feb 6, 2013
- Initiation Date
- Jan 3, 2013
- Termination Date
- Aug 2, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 44 units distributed
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.
Distribution Pattern
Worldwide Distribution - USA including CA, FL, IL, AL, OH, KY, TX , and Internationally to Australia, Columbia, Mexico, Netherlands, and Chile.
Code Information
Catalog Number: 909668 Lot Number Identification: 716710
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0753-2013
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026