Recall Z-2235-2024 ยท GAD Retractor
SEASPINE ORTHOPEDICS CORPORATION
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
| Date | Jun 28, 2024 (initiated May 17, 2024) |
| Status | Open, Classified |
| Reason | Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure |
| Root cause | Under Investigation by 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 |
| Quantity | 31 units |
| Distribution | United States Nationwide distribution in the states of Nevada, Texas, Michigan, Rhode Island, California, Oregon, Oklahoma, New York, Minnesota. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.