CLASS II Device recall · Reported 5 Feb 2020 · FDA Enforcement Report

Gibson Healthcare Membrane 6-9, Reference Number recalled

Collagen Matrix is recalling Gibson Healthcare Membrane 6-9, Reference Number 5303-299, distributed nationwide in the US. The recall was initiated on 5 Nov 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI: (01)00366975013255(17)210531; Lot Number PDMU19C1

Quantity recalled192 total

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0909-2020
FDA event ID: 84334
Recalling firm: Collagen Matrix, Oakland, NJ
Classification: Class II
Status: Terminated
Recall initiated: 5 Nov 2019
FDA classified: 29 Jan 2020
Reported: 5 Feb 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Surgical Instruments

Timeline

5 Nov 2019	Recall initiated by company
29 Jan 2020	Classified by FDA	+85 days
5 Feb 2020	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

GIBSON Healthcare Membrane 6-9, 30mm x 40mm, Reference Number 5303-299 - 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.

Where it was distributed

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.

Nationwide Arkansas Arizona California Colorado Florida Illinois Massachusetts Maryland Michigan Minnesota North Carolina New Jersey New York Oklahoma Pennsylvania South Carolina Texas Utah Virginia Washington

Questions about this recall

Is Gibson Healthcare Membrane 6-9, Reference Number 5303-299 recalled?

Yes. Collagen Matrix recalled Gibson Healthcare Membrane 6-9, Reference Number 5303-299 on 5 Nov 2019. The recall is Class II and its status is Terminated. Recall number Z-0909-2020.

Why was it recalled?

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

Which lots are affected?

UDI: (01)00366975013255(17)210531; Lot Number PDMU19C1

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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