Recall Z-1389-2019
Collagen Matrix, Inc. · initiated March 19, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Lot Number: OCF191255 UDI (01)00813954020884(17)211130(10)OCF191255
Reason for recall
Product was packaged in the wrong box; may have been placed inside a Neomem FLEXPLUS box instead of a Neomem box
FDA-determined cause: Under Investigation by firm
Action taken
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.
Details
- Recall number
- Z-1389-2019
- Initiated
- March 19, 2019
- Terminated
- May 12, 2020
- Product code
- NPL – Barrier, Animal Source, Intraoral
- Quantity
- 45 units -US;170 units OUS
- Distribution
- Worldwide distribution - US nationwide in the states of CA, FL and countries of Canada, Israel.
- Recalling firm
- Collagen Matrix, Inc., Allendale, NJ