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U.S. Department of Health and Human Services

Class 2 Device Recall Fathom PedicleBased Retractor

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 Class 2 Device Recall Fathom PedicleBased Retractorsee related information
Date Initiated by FirmMay 17, 2024
Date PostedJune 28, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2235-2024
Recall Event ID 94745
Product Classification Retractor - Product Code GAD
ProductBrand 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
Code Information UDI: 10889981300067 Lot Number: WT36299C
FEI Number 3012120772
Recalling Firm/
Manufacturer		 SEASPINE ORTHOPEDICS CORPORATION
5770 Armada Dr
Carlsbad CA 92008-4608
For Additional Information Contact
760-224-0177
Manufacturer Reason
for Recall		Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 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.
Quantity in Commerce31 units
DistributionUnited States Nationwide distribution in the states of Nevada, Texas, Michigan, Rhode Island, California, Oregon, Oklahoma, New York, Minnesota.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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