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
Reported: July 10, 2024 Initiated: May 17, 2024 #Z-2235-2024
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
Details
- Recalling Firm
- SEASPINE ORTHOPEDICS CORPORATION
- Units Affected
- 31 units
- Distribution
- United States Nationwide distribution in the states of Nevada, Texas, Michigan, Rhode Island, California, Oregon, Oklahoma, New York, Minnesota.
- Location
- Carlsbad, CA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by SEASPINE ORTHOPEDICS CORPORATION. Units affected: 31 units.
Why was this product recalled? ▼
Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 10, 2024. Severity: Moderate. Recall number: Z-2235-2024.
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