Brand Name: Meridian Angled Awl Fixed Product Name: Angled Awl Fixed… — Class II medical device recall Z-2357-2024
Ongoing recall by SEASPINE ORTHOPEDICS CORPORATION, reported 2024-07-24, distributed in AZ, CA, CO, FL, GA, IL, IN, MI…. Insufficient weld around the cap component of the instrument is insufficient to withstand impaction forces.
| Recall number | Z-2357-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | SEASPINE ORTHOPEDICS CORPORATION, Carlsbad, CA, United States |
| Recall initiated | 2024-06-04 |
| Classified | 2024-07-15 |
| Reported by FDA | 2024-07-24 |
| Distributed | AZ, CA, CO, FL, GA, IL, IN, MI, MN, MO, MT, NV, PA, SD, TN, TX, VA, WA |
| Quantity | 100 units |
| UPC / GTIN / UDI-DI | 10889981216368 |
| Lot numbers | TT0190H, TT0191H |
| Model numbers | RA2-003015 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2357-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.