Z-1389-2019 Class II Terminated
FDA device recall Z-1389-2019 was initiated by Collagen Matrix, Inc. on March 19, 2019 and is designated Class II. Reason for recall: Product was packaged in the wrong box; may have been placed inside a Neomem FLEXPLUS box instead of a Neomem box The recall status is terminated (terminated May 12, 2020). Affected quantity: 45 units -US;170 units OUS.
Recall Details
- Product Type
- Devices
- Report Date
- May 29, 2019
- Initiation Date
- March 19, 2019
- Termination Date
- May 12, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product 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.
Code Information
Lot Number: OCF191255 UDI (01)00813954020884(17)211130(10)OCF191255