Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade — Class II medical device recall Z-2235-2024
Ongoing recall by SEASPINE ORTHOPEDICS CORPORATION, reported 2024-07-10, distributed nationwide. Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure
| Recall number | Z-2235-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | SEASPINE ORTHOPEDICS CORPORATION, Carlsbad, CA, United States |
| Recall initiated | 2024-05-17 |
| Classified | 2024-06-28 |
| Reported by FDA | 2024-07-10 |
| Distributed | Nationwide (US) |
| Quantity | 31 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 10889981300067 |
| Lot numbers | WT36299C |
| Model numbers | MR2102050 |
Product
Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 50-80mm Model/Catalog Number: MR2102050 Product Description: Cranial Caudal Blade Component: Yes, a component of a retractor blade
Reason for recall
Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure
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-2235-2024. 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.