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Terminated

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.

FDA Recall Z-0911-2020 · Posted None

Recalling FirmCollagen Matrix Inc
Recall StatusTerminated
Product CodeNPL
Date Initiated2019-11-05
Date Terminated2020-08-03
Product Quantity192 total

Reason for Recall

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

Firm 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.

Root Cause

Labeling mix-ups

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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