TunneLoc Tibial Fixation Device 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.
FDA Recall Z-1071-2018 · Posted None
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Recalling FirmZimmer Biomet, Inc.
Recall StatusTerminated
Product CodeMBI
Date Initiated2017-10-11
Date Terminated2020-05-07
Product Quantity14,461
Reason for Recall
Gamma sterilization validation testing indicates the sterilization dose for the product may not be adequate.
Firm 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
Root Cause
Vendor change control
Distribution Pattern
US Nationwide Distribution
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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