Collagen Matrix Inc: Medical Device Recall in 2020 - (Recall #: Z-0912-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

GIBSON Healthcare Membrane Extended, 30mm x 40mm, Reference Number 5303-342 - Product Usage: Indicated for use in oral surgical procedures as a resorbable material for use in augmentation around implants placed in immediate extraction sockets, delayed extraction sockets; localized ridge augmentation for later implantation; alveolar ridge reconstruction for prosthetic treatment; filling of bone defects; guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in periodontal defects.

Product Classification:

Class II

Date Initiated: November 5, 2019

Date Posted: February 5, 2020

Recall Number: Z-0912-2020

Event ID: 84334

Reason for Recall:

The products may have been packaged with an incorrect Instructions for Use.

Status: Terminated

Product Quantity: 192 total

Code Information:

UDI: (01)00366975013293(17)200630; Lot Number EPDMU18H1

Distribution Pattern:

US Nationwide distribution in the states of AR, AZ, CA, CO, FL, IL, MA, MD, MI, MN, NC, NJ, NY, OK, PA, SC, TX, UT, VA, and WA.

Voluntary or Mandated:

Voluntary: Firm initiated