FDA Device recall Z-0668-2022
DuraMatrix-Onlay Collagen Dura Substitute Membrane 4 inches x 5 inches (10.0cm x 12.5cm) REF: CDSLM45
- FDA Device
- Class II
- terminated
- Published 2022-03-02
On 2022-03-02 the FDA classified a Class II recall of DuraMatrix-Onlay Collagen Dura Substitute Membrane 4 inches x 5 inches (10.0cm x 12.5cm) REF: CDSLM45 by Collagen Matrix, citing outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk of patient infection, which could lead to revision surgery.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0668-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-12-13 |
| Published | 2022-03-02 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Collagen Matrix |
| Distribution | US |
Product
DuraMatrix-Onlay Collagen Dura Substitute Membrane 4 inches x 5 inches (10.0cm x 12.5cm) REF: CDSLM45
Reason
Outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk of patient infection, which could lead to revision surgery
Identifiers
| code_info | Model Number CDSLM45 Lot Number 2107292022 Exp Date:7/31/2024 UDI: (01)00813954020273(17)240731(10)2107292022 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0668-2022%22
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