CLASS II Device recall · Reported 21 Mar 2018 · FDA Enforcement Report
TunneLoc Tibial Fixation Device recalled by Zimmer Biomet
Zimmer Biomet is recalling TunneLoc Tibial Fixation Device, distributed nationwide in the US. The recall was initiated on 11 Oct 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1071-2018
- FDA event ID
- 79263
- Recalling firm
- Zimmer Biomet, Warsaw, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Oct 2017
- FDA classified
- 15 Mar 2018
- Reported
- 21 Mar 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Hip & Knee Implants
Timeline
| 11 Oct 2017 | Recall initiated by company | |
| 15 Mar 2018 | Classified by FDA | +155 days |
| 21 Mar 2018 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Gamma sterilization validation testing indicates the sterilization dose for the product may not be adequate.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide Distribution
Stores named: Walmart
Questions about this recall
Is TunneLoc Tibial Fixation Device recalled?
Yes. Zimmer Biomet recalled TunneLoc Tibial Fixation Device on 11 Oct 2017. The recall is Class II and its status is Terminated. Recall number Z-1071-2018.
Why was it recalled?
Gamma sterilization validation testing indicates the sterilization dose for the product may not be adequate.
Which lots are affected?
906512, 906513, 906514, 906515
Where was it sold?
US Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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