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U.S. Department of Health and Human Services

Class 2 Device Recall Smooth or threaded metallic bone fixation fastener

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  Class 2 Device Recall Smooth or threaded metallic bone fixation fastener see related information
Date Initiated by Firm October 11, 2017
Create Date March 15, 2018
Recall Status1 Terminated 3 on May 07, 2020
Recall Number Z-1072-2018
Recall Event ID 79263
510(K)Number K103145  
Product Classification Fastener, fixation, nondegradable, soft tissue - Product Code MBI
Product TunneLoc Tibial Fixation Device (Within an ACL Kit)

Product Usage:
To provide fixation of soft tissue grafts within the tibial tunnel during anterior cruciate ligament (ACL) and/or posterior cruciate ligament (PCL) reconstruction.
Code Information The kits that include the TunneLoc products, ACL in a box, PNs 906532, 906533, 906534, and 906535 are packed in a box alongside the Instructions for use and is distributed non-sterile .
Recalling Firm/
Zimmer Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
Manufacturer Reason
for Recall
Gamma sterilization validation testing indicates the sterilization dose for the product may not be adequate.
FDA Determined
Cause 2
Vendor change control
Action Zimmer Biomet sent an URGENT MEDICAL DEVICE RECALL letter dated October 16, 2017 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to review inventory and quarantine affected product, which will be returned to Biomet through a sales representative. Questions or concerns can be directed to 574-371-3071
Distribution US Nationwide Distribution
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MBI and Original Applicant = BIOMET SPORTS MEDICINE