Zimmer Biomet, Inc.: Medical Device Recall in 2018 - (Recall #: Z-1072-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: October 11, 2017

Date Posted: March 21, 2018

Recall Number: Z-1072-2018

Event ID: 79263

Reason for Recall:

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

Status: Terminated

Product Quantity:

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 .

Distribution Pattern:

US Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated