Duraform Dural Graft Implant, Size 3x3 , Model Number 80-1477US Lot CT007694

Out of specification endotoxin levels.

An 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 [email protected] 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 [email protected] for any additional questions.