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U.S. Department of Health and Human Services

Enforcement Report - Week of February 6, 2013

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Event Detail

Event ID 64004
Product Type Devices
Status Ongoing
Recalling Firm Biomet, Inc.
City Warsaw
State IN
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-01-03
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Worldwide Distribution - USA including CA, FL, IL, AL, OH, KY, TX , and Internationally to Australia, Columbia, Mexico, Netherlands, and Chile.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Catalog Number: 909668 Lot Number Identification: 716710 Class II Thru hole at the tip of the screw is undersized. 44 units distributed Z-0753-2013
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