Product Wiki · Recalls · U.S. FDA — Device Enforcement

GIBSON Healthcare Membrane Extended, 20mm x 30mm, Reference Number… — recall Z-0911-2020

U.S. FDA — Device Enforcement · United States · 2019-11-05 · Class II

As described by U.S. FDA — Device Enforcement: 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

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0911-2020
Date of alert
2019-11-05
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Collagen Matrix Inc
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
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.
Barcode (EAN/GTIN)
00366975013286
Reported risk: The products may have been packaged with an incorrect Instructions for Use.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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