Z-1072-2018Class II

TunneLoc Tibial Fixation Device (Within an ACL Kit)

Name: Z-1072-2018 TunneLoc Tibial Fixation Device (Within an ACL Kit)
Creator: Zimmer Biomet, Inc.
Published: 2017-10-11
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2017-10-11 / Terminated / root cause: supplier

FDA source

Zimmer Biomet, Inc. began a recall of TunneLoc Tibial Fixation Device (Within an ACL Kit) Product Usage: To provide fixation of soft tissue grafts within the tibial tunnel during anterior cruciate... on 2017-10-11. FDA classified it as Class II and gives the reason as "Gamma sterilization validation testing indicates the sterilization dose for the product may not be adequate". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as supplier.

Recall record

Recall number: Z-1072-2018
Classification: Class II
Status: Terminated
Initiated: 2017-10-11
Posted: 2018-03-15
Terminated: 2020-05-07
Recalling firm: Zimmer GmbH
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.
Product code: MBI Fastener, Fixation, Nondegradable, Soft Tissue
Reason for recall: Gamma sterilization validation testing indicates the sterilization dose for the product may not be adequate.
Root cause tag: supplier
FDA 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
Distribution: US Nationwide Distribution
Product codes and lots: 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 .

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1072-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1071-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-15
Z-1072-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-15

Product code MBI

K103145Class IIHammerloc Tm Tibial Fixation DeviceBiomet Sports Medicine / cleared 2011-02-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)