Class II

Medical Device Recall: 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 · June 4, 2024

Reason for Recall

Insufficient weld around the cap component of the instrument is insufficient to withstand impaction forces.

Distribution

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

Quantity Affected

100 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2357-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.