Neomem Resorbable Collagen Membrane, 15 mm x 20 mm Reference Number (model): N1520 - Product Usa...

FDA Device Recall #Z-1389-2019 — Class II — March 19, 2019

Recall Summary

Recall Number Z-1389-2019
Classification Class II — Moderate risk
Date Initiated March 19, 2019
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Collagen Matrix, Inc.
Location Allendale, NJ
Product Type Devices
Quantity 45 units -US;170 units OUS

Product Description

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 Pattern

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

Lot / Code Information

Lot Number: OCF191255 UDI (01)00813954020884(17)211130(10)OCF191255

Other Recalls from Collagen Matrix, Inc.

Recall # Classification Product Date
Z-0668-2022 Class II DuraMatrix-Onlay Collagen Dura Substitute Memb... Dec 13, 2021
Z-0669-2022 Class II RESODURA matrix onlay 10.0 cm x 12.5 cm - indic... Dec 13, 2021
Z-0414-2019 Class III BioMend Extend, REF# 0142Z, Synthetic bone graf... Aug 16, 2018

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.