Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 50-80mm Model/Catalog Number: MR2102050 Product Desc
FDA device recall Z-2235-2024 · posted 2024-06-28 · Open, Classified
Recall details
- Recalling firm
- SEASPINE ORTHOPEDICS CORPORATION
- Reason for recall
- Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- GAD
- Quantity affected
- 31 units
- Distribution
- United States Nationwide distribution in the states of Nevada, Texas, Michigan, Rhode Island, California, Oregon, Oklahoma, New York, Minnesota.
- Date initiated
- 2024-05-17
- Date posted
- 2024-06-28
- Location
- Carlsbad, CA
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