Brand Name: Fathom Pedicle-Based Retractor Product recall
Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 35-55mm Model/Catalog Number: MR2102035 Product Description: Cranial Caudal Blade…
Why was Brand Name: Fathom Pedicle-Based Retractor Product recalled?
Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI: 10889981300050 Lot Number: WT36298C
- Product
- Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 35-55mm Model/Catalog Number: MR2102035 Product Description: Cranial Caudal Blade…
- Recalling firm
- SEASPINE ORTHOPEDICS CORPORATION
- Quantity
- 21 units
- Distribution
- United States Nationwide distribution in the states of Nevada, Texas, Michigan, Rhode Island, California, Oregon, Oklahoma, New York, Minnesota.
- Recall date
- July 10, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)