Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 35-55mm Model/Catalog Number: MR2102035 Product Description: Cranial Caudal Blade Component: Yes, a component of a retractor blade
- Company
- Seaspine Orthopedics Corporation
- Recall Initiated
- May 17, 2024
- Posted
- June 28, 2024
- Recall Number
- Z-2234-2024
- Quantity
- 21 units
- Firm Location
- Carlsbad, CA
Reason for Recall
Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure
Distribution
United States Nationwide distribution in the states of Nevada, Texas, Michigan, Rhode Island, California, Oregon, Oklahoma, New York, Minnesota.
Lot / Code Info
UDI: 10889981300050 Lot Number: WT36298C
Root Cause
Under Investigation by firm
Action Taken
On May 17, 2024, SeaSpine Orthopedics Corporation issued a "Urgent: Medical Device Recall" notification. via E-Mail (DocuSign) to affected consignees. 1. Please return the entire Fathom set to SeaSpine s Carlsbad facility for evaluation and potential rework of the affected blades. A shipping label is attached for your convenience. 2. To support your upcoming cases, please continue to utilize the loaner pool. Upon receipt of the affected inventory, it will take approximately three weeks for rework and return to the loaner pool. 3. Once the inventory has been returned, please acknowledge via DocuSign.