Food, drugs, devices › Zimmer Biomet, Inc.
Device recall: TunneLoc Tibial Fixation Device Product Usage: To provide fixation of soft tissue grafts within the tibial tunnel during
Zimmer Biomet, Inc. (Warsaw, IN) initiated this device recall on 11 Oct 2017; FDA lists 2 product records under event 79263, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 93% of the 1,091 device enforcement events initiated in 2017 carry the same class.
Status: Terminated, terminated 7 May 2020. Initiation: voluntary: firm initiated. Zimmer Biomet, Inc. has 144 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Zimmer Biomet, Inc., Warsaw, IN.
Reason for recall
"Gamma sterilization validation testing indicates the sterilization dose for the product may not be adequate."
Distribution
"US Nationwide Distribution"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1071-2018 | 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. | 14,461 | Class II | Terminated | 21 Mar 2018 |
| Z-1072-2018 | 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. | — | Class II | Terminated | 21 Mar 2018 |
Context
Other enforcement events for Zimmer Biomet, Inc.
All 144 events for Zimmer Biomet, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Gamma sterilization validation testing indicates the sterilization dose for the product may not be adequate."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide Distribution"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 7 May 2020. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.