Recall Z-1389-2019— Collagen Matrix, Inc.

Name: FDA recall Z-1389-2019
Creator: U.S. Food and Drug Administration
Published: 2019-03-19

Class II · Terminated

Class II FDA medical device recall by Collagen Matrix, Inc., initiated 2019-03-19, terminated 2020-05-12. It names 2 FDA 510(k) clearances: K011695, K003339. 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: Product was packaged in the wrong box; may have been placed inside a Neomem FLEXPLUS box instead of a Neomem box.

Recalling firm: Collagen Matrix, Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-03-19
Terminated: 2020-05-12
Firm location: Allendale, NJ, United States

510(k) clearances named in this recall

2 on FDA's record

K011695 — COLLAGEN DENTAL MEMBRANECollagen Matrix, Inc.·cleared 2001-08-07
K003339 — COLLAGEN PERIODONTAL MEMBRANECollagen Matrix, Inc.·cleared 2001-01-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.