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U.S. Department of Health and Human Services

Class 2 Device Recall DURAFORM Dural Graft Implant

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 Class 2 Device Recall DURAFORM Dural Graft Implantsee related information
Date Initiated by FirmSeptember 26, 2024
Date PostedOctober 30, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0262-2025
Recall Event ID 95466
510(K)NumberK152481 
Product Classification Dura substitute - Product Code GXQ
ProductDuraform Dural Graft Implant, Size 3x3 , Model Number 80-1477US Lot CT007694
Code Information Part# 80-1477US Lot# CT007694 UDI# 10886704079477
Recalling Firm/
Manufacturer		 Integra LifeSciences Corp.
1100 Campus Rd
Princeton NJ 08540-6650
For Additional Information ContactLacey Gigante
1-609-212-9004
Manufacturer Reason
for Recall		Out of specification endotoxin levels.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionAn URGENT - FIELD SAFETY NOTICE dated 9/26/24 was sent to the customer. Actions to be Taken by Distributors: 1. If you do have the affected product listed in Table 1, remove the product from further distribution and place them in quarantine. 2. If you do have affected product, check the box on the enclosed form I do have affected product. 3. If you do not have affected product, check the box, I do not have affected product. 4. Complete the attached Distributor Reply Form in Appendix 1 and return to FCA1@integralife.com or electronic FAX to 1-609-750-4220. 5. Keep a copy of the form for your records. 6. Please manage the returns with your customers per your process : credit can be provided if your customers have any product to return and they return it to you. 7. Forward a copy of the enclosed Field Safety Notice to any of your customers that have purchased the affected product. If you need a copy of a Customer Reply Form , use the one in Appendix 2, as applicable. PLEASE NOTE THAT REGARDLESS OF WHETHER YOU HAVE THE AFFECTED PRODUCT OR NOT A COMPLETED ACKNOWLEDGEMENT IS REQUIRED Finally, if required by the national medical device regulation of your distribution area, please ensure this Field Safety Corrective Action is notified to the national competent authorities. Thank you for your cooperation with this Field Safety Corrective Action and for returning the attached Reply Form. See return instructions on top of the reply forms in Appendix 1. Please feel free to contact our Post Market Surveillance Department at FCA1@integralife.com for any additional questions.
Quantity in Commerce128 units
DistributionChina
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.
510(K) Database510(K)s with Product Code = GXQ
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