FDA Device recall Z-1389-2019
Neomem Resorbable Collagen Membrane, 15 mm x 20 mm Reference Number (model): N1520 - Product Usage: Neomem is a bioresorbable, implantable…
- FDA Device
- Class II
- terminated
- Published 2019-05-29
On 2019-05-29 the FDA classified a Class II recall of Neomem Resorbable Collagen Membrane, 15 mm x 20 mm Reference Number (model): N1520 - Product Usage: Neomem is a bioresorbable, implantable… by Collagen Matrix, citing product was packaged in the wrong box; may have been placed inside a Neomem FLEXPLUS box instead of a Neomem box.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1389-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-03-19 |
| Published | 2019-05-29 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Collagen Matrix |
| Distribution | US |
Product
Neomem Resorbable Collagen Membrane, 15 mm x 20 mm Reference Number (model): N1520 - Product Usage: Neomem is a bioresorbable, implantable collagen material that is intended for use in dental surgery procedures as a material for placement in the area of dental implant, bone defect or ridge reconstruction to aid in wound healing post dental surgery. Neomem¿ is also intended for use in patients with moderate to severe periodontal disease as a material for placement in periodontal defects to aid in wound healing of periodontal tissue.
Reason
Product was packaged in the wrong box; may have been placed inside a Neomem FLEXPLUS box instead of a Neomem box
Identifiers
| code_info | Lot Number: OCF191255 UDI (01)00813954020884(17)211130(10)OCF191255 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1389-2019%22
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