Recall Z-0262-2025 ยท GXQ Dura Substitute
Integra LifeSciences Corp.
Duraform Dural Graft Implant, Size 3x3 , Model Number 80-1477US Lot CT007694
| Date | Oct 30, 2024 (initiated Sep 26, 2024) |
| Status | Open, Classified |
| Reason | Out of specification endotoxin levels. |
| Root cause | Nonconforming Material/Component |
| Action | 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 FCA1@integralife.com or electronic FAX to 1-609-750-4220. 5. Keep a copy of the form fo |
| Quantity | 128 units |
| Distribution | China |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152481 | DURAFORM Dural Graft Implant Codman & Shurtleff, Inc., Oct 30, 2015 |