FDAFDA · Food and drugs·Recall number Z-0705-2022
Everest MI XT Inner Dilator, Catalog Number 5101-90167
Published March 9, 2022 · Recall initiated: January 13, 2022
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- K2M, Inc
- Distributor
- Worldwide distribution - US Nationwide.
- Lot
- GTIN: 10888857261204; Lot Numbers: JUJF KFMV KUPG KYYU MDRB NDMK NDMX NXJK
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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