Neomem Resorbable Collagen Membrane — Class II medical device recall Z-1389-2019
Terminated recall by Collagen Matrix, Inc., reported 2019-05-29, distributed nationwide. Product was packaged in the wrong box; may have been placed inside a Neomem FLEXPLUS box instead of a Neomem b
| Recall number | Z-1389-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Collagen Matrix, Inc., Allendale, NJ, United States |
| Recall initiated | 2019-03-19 |
| Classified | 2019-05-22 |
| Reported by FDA | 2019-05-29 |
| Terminated | 2020-05-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, IL |
| UPC / GTIN / UDI-DI | 00813954020884 |
| Lot numbers | OCF191255 |
| Model numbers | N1520 |
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 for recall
Product was packaged in the wrong box; may have been placed inside a Neomem FLEXPLUS box instead of a Neomem box
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1389-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.