# FDA recall Z-1389-2019

> **Collagen Matrix, Inc.** · Class II · device recall initiated 2019-03-19.

## 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

## Distribution

Worldwide distribution - US nationwide in the states of CA, FL  and countries of Canada, Israel.

## Key facts

- **Recall number:** Z-1389-2019
- **Recalling firm:** Collagen Matrix, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-03-19
- **Report date:** 2019-05-29
- **Termination date:** 2020-05-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Allendale, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1389-2019

## Citation

> AI Analytics. FDA recall Z-1389-2019. Retrieved 2026-07-19 from https://api.ai-analytics.org/recall/Z-1389-2019. Source: US FDA. Licensed CC0.

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