Recall Z-2235-2024— SEASPINE ORTHOPEDICS CORPORATION
Class II · Ongoing
Class II FDA medical device recall by SEASPINE ORTHOPEDICS CORPORATION, initiated 2024-05-17. FDA's recall record names no specific 510(k) clearance for this event. 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: Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure.
- Recalling firm
- SEASPINE ORTHOPEDICS CORPORATION
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-05-17
- Firm location
- Carlsbad, CA, United States
Product description
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.