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
FDA Recall Z-2235-2024 · Posted 2024-06-28
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Recalling FirmSEASPINE ORTHOPEDICS CORPORATION
Recall StatusOpen, Classified
Product CodeGAD
Date Initiated2024-05-17
Product Quantity31 units
Reason for Recall
Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure
Firm Action
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.
Root Cause
Under Investigation by firm
Distribution Pattern
United States Nationwide distribution in the states of Nevada, Texas, Michigan, Rhode Island, California, Oregon, Oklahoma, New York, Minnesota.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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