FDA Medical Device Recalls (openFDA)
Zimmer Biomet, Inc.: 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.
- Recall number
- Z-1072-2018
- Recalling firm
- Zimmer Biomet, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2017-10-11
- Posted
- not on file
- Terminated
- 2020-05-07
- Reason
- Gamma sterilization validation testing indicates the sterilization dose for the product may not be adequate.
- Root cause
- 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
- Quantity
- not on file
- Distribution
- US Nationwide Distribution
- Lot, serial or model codes
- 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 .
- 510(k) numbers
- ["K103145"]
- PMA numbers
- not on file
- Product code
- MBI
- Firm FEI
- 1825034
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28