Collagen Matrix, Inc. Recall 89495
Description: DuraMatrix-Onlay Collagen Dura Substitute Membrane 4 inches x 5 inches (10.0cm x 12.5cm) REF: CDSLM45
Collagen Matrix, Inc. Recall 89495 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0668-2022 |
| Event ID | 89495 |
| Event Description | DuraMatrix-Onlay Collagen Dura Substitute Membrane 4 inches x 5 inches (10.0cm x 12.5cm) REF: CDSLM45 |
| Product Type | Devices |
| 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. |
| Quantity | 68 units |
| Recall Reason | Outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk of patient infection, which could lead to revision surgery |
| Device Classification | 20220302 |
| Device Code Info | Model Number CDSLM45 Lot Number 2107292022 Exp Date:7/31/2024 UDI: (01)00813954020273(17)240731(10)2107292022 |
| Center Classification Date | 20220224 |
| Recall Initiation Date | 20211213 |
| Recalling Firm | Collagen Matrix, Inc. |
| Initial Notification | Letter |
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