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U.S. Department of Health and Human Services

Class 2 Device Recall Graft Tube

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 Class 2 Device Recall Graft Tubesee related information
Date Initiated by FirmSeptember 16, 2024
Date PostedOctober 17, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0117-2025
Recall Event ID 95341
Product Classification Orthopedic manual surgical instrument - Product Code LXH
ProductThe Graft Tube is an optional instrument which, as designed, can be filled with flowable graft material, then advanced through the Access Portal. A Push Rod is then used to facilitate the manual deployment of the graft material out of the Graft Tube and adjacent to where the implant is to be placed, as supported within the Surgical Technique Guide.
Code Information UDI-DI: M7403120056, Catalog Number: 312-0056, part Number: 33-09-14. Lot Numbers: CH20003, BE22003
Recalling Firm/
Manufacturer		 Spineology, Inc.
7800 3rd St N Ste 600
Saint Paul MN 55128-5455
For Additional Information ContactMegan Polos
651-256-8500 Ext. 8468
Manufacturer Reason
for Recall		Possible detachment of the Graft Tube shaft from the Graft Tube funnel head when it is not used as instructed by our surgical technique.
FDA Determined
Cause 2		Under Investigation by firm
ActionSpineology began notification of medical institutions on 09/16/2024, direct sales representatives on 09/18/2024 and distributors on 09/19/2024 via letter. Instructions included to notify appropriate staff of the action and to complete and return the response form. Spineology will be performing a correction to update the surgical technique labeling and a removal will be conducted to replace current Graft Tubes within field inventory. Distributors were instructed to notify customers if further distributed.
Quantity in Commerce190 units
DistributionPending
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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