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Terminated

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.

FDA Recall Z-1389-2019 · Posted None

Recalling FirmCollagen Matrix, Inc.
Recall StatusTerminated
Product CodeNPL
Date Initiated2019-03-19
Date Terminated2020-05-12
Product Quantity45 units -US;170 units OUS

Reason for Recall

Product was packaged in the wrong box; may have been placed inside a Neomem FLEXPLUS box instead of a Neomem box

Firm Action

Citagenix with the Manufacturer, Collagen Matrix, Inc. issued on, March 19, 2019, the Recall Notice via email advising of the problem, health risk, and action to take: determine the quantity on hand and quarantine. Check distribution records and determine whether any of the affected product was distributed to your customers. Complete the attached Acknowledgement of Receipt Form with the appropriate information and return within 72 hours of receiving this notice to initiate additional recall activities where applicable. Upon receipt of the completed form, Citagenix will provide a prepaid return shipping label with further instructions for returning product that remains in your possession and/or with additional recall activities. If you have any questions after reviewing this notice, please call 1-877-243-6724 between 8:00 am and 5:00 pm EST, Monday through Friday.

Root Cause

Under Investigation by firm

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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