FDAFDA · Food and drugs·Recall number Z-2357-2024
Brand Name: Meridian Angled Awl Fixed Product Name: Angled Awl Fixed Model/Catalog Number: RA2-003015 Product Description: Surgical Awl Component: No
Published July 24, 2024 · Recall initiated: June 4, 2024
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
Insufficient weld around the cap component of the instrument is insufficient to withstand impaction forces.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- SEASPINE ORTHOPEDICS CORPORATION
- Distributor
- The product was distributed to the following US states: Nevada, Colorado, Texas, Washington, Indiana, Georgia, Michigan, Florida, Pennsylvania, Illinois, Tennessee, Virginia, Missouri, South Dakota, California, Montana, Minnesota, Arizona
- Lot
- Lot Code: UDI 10889981216368 Lot Numbers TT0190H, TT0191H
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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