Class II — SEASPINE ORTHOPEDICS CORPORATION
| Recalling firm | SeaSpine Orthopedics Corporation |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Insufficient weld around the cap component of the instrument is insufficient to withstand impaction forces. |
| Product | Brand Name: Meridian Angled Awl Fixed Product Name: Angled Awl Fixed Model/Catalog Number: RA2-003015 Product Description: Surgical Awl Component: No |
| Quantity | 100 units |
| 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 |
| Initiated | 2024-06-04 |
| Classified | 2024-07-15 |
| Recall number | Z-2357-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — SEASPINE ORTHOPEDICS CORPORATION (Z-2357-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/94872/
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