Z-0911-2020Class II

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

Name: Z-0911-2020 GIBSON Healthcare Membrane Extended, 20mm x 30mm, Reference Number 5303-324 -
Creator: Collagen Matrix Inc
Published: 2019-11-05
License: https://open.fda.gov/license/

Collagen Matrix, Inc / initiated 2019-11-05 / Terminated / root cause: labeling and UDI

FDA source

Collagen Matrix Inc began a recall of GIBSON Healthcare Membrane Extended, 20mm x 30mm, Reference Number 5303-324 - Product Usage: Indicated for use in oral surgical procedures as a resorbable... on 2019-11-05. FDA classified it as Class II and gives the reason as "The products may have been packaged with an incorrect Instructions for Use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0911-2020
Classification: Class II
Status: Terminated
Initiated: 2019-11-05
Posted: 2020-01-29
Terminated: 2020-08-03
Recalling firm: Collagen Matrix, Inc
Product: 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.
Product code: NPL Barrier, Animal Source, Intraoral
Reason for recall: The products may have been packaged with an incorrect Instructions for Use.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: 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.
Quantity in commerce: 192 total
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 codes and lots: UDI: (01)00366975013286(17)200630; Lot Number EPDMU18H1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0911-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0907-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-05	2020-01-29
Z-0908-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-05	2020-01-29
Z-0909-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-05	2020-01-29
Z-0910-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-05	2020-01-29
Z-0911-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-05	2020-01-29
Z-0912-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-05	2020-01-29

Product code NPL

K100156Class IICollagen Dental Membrane VCollagen Matrix, Inc. / cleared 2010-08-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)