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GIBSON HEALTHCARE recallZ-0911-2020 · Collagen Matrix Inc · initiated Nov 5, 2019

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Collagen Matrix Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Labeling mix-ups

What the company is doing

Urgent Medical Device Recall Notice letters dated 11/5/19 were sent to customers. IMMEDIATE ACTIONS TO BE TAKEN BY THE CUSTOMER 1. Check your inventory to determine if any of the affected product remains in your stock and segregate all affected units from your inventory for return. 2. Complete the attached Certificate of Acknowledgement form with the appropriate information and return within 5 days of receiving this notice. The completed form can be emailed to [email protected] or returned by mail to: Product Recall Collagen Matrix, Inc. 15 Thornton Road Oakland, NJ 07436 Upon receipt of the completed form, Benco Dental will ship replacement product and a prepaid return shipping label will be provided with further instructions for returning product that remains in your possession. OTHER INFORMATION If you have any questions after reviewing this notice, please call 1-800-462-3626 between 7:00am and 8:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a prompt to leave a voicemail.

Recall details

Recall number
Z-0911-2020
Status
Terminated
Initiated by the company
Nov 5, 2019
Recalling firm
Collagen Matrix Inc
Quantity
192 total
Product code
NPL
FDA submissions
K100156
Distribution
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.

Product description

GIBSON Healthcare Membrane Extended, 20mm x 30mm, Reference Number 5303-324 - 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.

Code information (models, lots, serial numbers)

UDI: (01)00366975013286(17)200630; Lot Number EPDMU18H1

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 84334).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page