FDA-Device2024-07-24Class II
Brand Name: Meridian Angled Awl Fixed Product Name: Angled Awl Fixed Model/Catalog Number: RA2-003015 Product Description: Surgical Awl Component: No
SEASPINE ORTHOPEDICS CORPORATION
Hazard
Insufficient weld around the cap component of the instrument is insufficient to withstand impaction forces.
Sold states
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
Affected count
100 units
Manufactured in
5770 Armada Dr, Carlsbad, CA, United States
Products
Brand Name: Meridian Angled Awl Fixed Product Name: Angled Awl Fixed Model/Catalog Number: RA2-003015 Product Description: Surgical Awl Component: No
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2357-2024Don't want to check this manually?
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