FDA recall Z-1071-2018

Product

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.

Reason for recall

Gamma sterilization validation testing indicates the sterilization dose for the product may not be adequate.

Distribution

US Nationwide Distribution

Key facts

Status

Terminated

Initiation date

2017-10-11

Report date

2018-03-21

Termination date

2020-05-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1071-2018