Reported Mar 9, 2022 · Ongoing
Everest MI XT Outer Dilator, Catalog Number 5101-90168
K2M, 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: K2M, Inc · 600 Hope Pkwy SE · Leesburg, VA · 20175-4428
Is this the product you have?
- Everest MI XT Outer Dilator, Catalog Number 5101-90168
- Lot codes and dates
- GTIN10888857261211
- Lot NumbersHCBN HCBP JUJJ KFMX KUPH KYYV MDPF NAKJ NDGT PCCN
- Amount recalled
- 686 Total Devices
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Stryker received two (2) complaints for units from specific lots of Inner and Outer Dilators not fitting together properly during a surgical procedure. Some dilators from these lots and from other lots were subsequently determined to be affected by a manufacturing nonconformance.
This product could cause temporary or reversible health problems — stop using it.
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