Recall Z-2357-2024— SEASPINE ORTHOPEDICS CORPORATION

Name: FDA recall Z-2357-2024
Creator: U.S. Food and Drug Administration
Published: 2024-06-04

Class II · Ongoing

Class II FDA medical device recall by SEASPINE ORTHOPEDICS CORPORATION, initiated 2024-06-04. FDA's recall record names no specific 510(k) clearance for this event. Product: Brand Name: Meridian Angled Awl Fixed Product Name: Angled Awl Fixed Model/Catalog Number: RA2-003015 Product Description: Surgical Awl Component: No. Reason: Insufficient weld around the cap component of the instrument is insufficient to withstand impaction forces..

Recalling firm: SEASPINE ORTHOPEDICS CORPORATION
Classification: Class II
Status: Ongoing
Initiated: 2024-06-04
Firm location: Carlsbad, CA, United States

Product description

Brand Name: Meridian Angled Awl Fixed Product Name: Angled Awl Fixed Model/Catalog Number: RA2-003015 Product Description: Surgical Awl Component: No

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.