Class II — Collagen Matrix, Inc.
| Recalling firm | COLLAGEN MATRIX, INC. |
|---|---|
| Registered facility | View this company's 3 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Product was packaged in the wrong box; may have been placed inside a Neomem FLEXPLUS box instead of a Neomem box |
| 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. |
| Quantity | 45 units -US;170 units OUS |
| Distribution | Worldwide distribution - US nationwide in the states of CA, FL and countries of Canada, Israel. |
| Initiated | 2019-03-19 |
| Classified | 2019-05-22 |
| Terminated | 2020-05-12 |
| Recall number | Z-1389-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Collagen Matrix, Inc. (Z-1389-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/82638/
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