SEASPINE ORTHOPEDICS CORPORATION: Device Recall
Recall #Z-2357-2024 · 06/04/2024
Class II: Risk
Recall Details
- Recall Number
- Z-2357-2024
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- SEASPINE ORTHOPEDICS CORPORATION
- Status
- Ongoing
- Date Initiated
- 06/04/2024
- Location
- Carlsbad, CA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 100 units
Reason for Recall
Insufficient weld around the cap component of the instrument is insufficient to withstand impaction forces.
Product Description
Brand Name: Meridian Angled Awl Fixed Product Name: Angled Awl Fixed Model/Catalog Number: RA2-003015 Product Description: Surgical Awl Component: No
Distribution Pattern
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
Other Recalls by SEASPINE ORTHOPEDICS CORPORATION
- Class II: Risk 11/17/2025
- Class II: Risk 08/06/2025
- Class II: Risk 10/29/2024
- Class II: Risk 10/29/2024
- Class II: Risk 05/17/2024
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.