Reported Mar 21, 2018 · Terminated
TunneLoc Tibial Fixation Device Product Usage: To provide fixation of soft tissue grafts within the tibial tunnel…
Zimmer Biomet, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zimmer Biomet, Inc. · 56 E Bell Dr · Warsaw, IN · 46582-6989
Is this the product you have?
- TunneLoc
- Tibial Fixation Device Product UsageTo provide fixation of soft tissue grafts within the tibial tunnel during anterior cruciate ligament (ACL) and/or posterior cruciate ligament (PCL) reconstruction
- Lot codes and dates
906512906513906514906515
- Amount recalled
- 14,461
This recall covers 59 products
The agency filed one notice per product. You are reading one of them; the other 58 are below.
46 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
Gamma sterilization validation testing indicates the sterilization dose for the product may not be adequate.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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