Recall Z-0753-2013— Biomet, Inc.

Name: FDA recall Z-0753-2013
Creator: U.S. Food and Drug Administration
Published: 2013-01-03

Class II · Terminated

Class II FDA medical device recall by Biomet, Inc., initiated 2013-01-03, terminated 2013-08-02. It names one FDA 510(k) clearance: K934469. 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..

Recalling firm: Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-01-03
Terminated: 2013-08-02
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K934469 — ARTHROTEK INTERFERENCE SCREWBiomet, Inc.·cleared 1994-02-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.