Recall Z-0669-2022 ยท GXQ Dura Substitute
Collagen Matrix, Inc.
RESODURA matrix onlay 10.0 cm x 12.5 cm - indicated as dural substitutes for the repair of dura matter. REF: DUMO10125
| Date | Feb 24, 2022 (initiated Dec 13, 2021) |
| Status | Terminated |
| Reason | Outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk of patient infection, which could lead to revision surgery |
| Root cause | Nonconforming Material/Component |
| Action | On Monday, December 6, 2021, Collagen Matrix Inc began informing the distributors (initial consignees) to place the lot in question on ship hold. On Monday, December 13, 2021, Collagen Matrix began issuing Urgent Medical Device Recall Notice letter to distributors via email. Letter states reason for recall, health risk and action to take: Check your inventory and that of your sub-distributors if applicable to determine if any of the affected product remains in stock and segregate all affected units from your inventory for return. Complete the Certificate of Acknowledgement form with the |
| Quantity | 10 units |
| Distribution | DuraMatrix-Onlay distributed US Nationwide in the states of FL, IN, Puerto Rico, and the countries of Canada, Chile, and Colombia. RESODURA matrix onlay distributed in Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061487 | DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE - ONLAY AND SUTURABLE Collagen Matrix, Inc., Jun 26, 2006 |