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U.S. Department of Health and Human Services

Class 2 Device Recall GIBSON

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  Class 2 Device Recall GIBSON see related information
Date Initiated by Firm November 05, 2019
Create Date January 29, 2020
Recall Status1 Terminated 3 on August 03, 2020
Recall Number Z-0907-2020
Recall Event ID 84334
510(K)Number K100156  
Product Classification Barrier, animal source, intraoral - Product Code NPL
Product GIBSON Healthcare Membrane 6-9, 15mm x 20mm, Reference Number 5303-226 - 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 UDI: (01)00366975013248(17)200630; Lot Number PDMU18F1, PDMU19A1
Recalling Firm/
Manufacturer		 Collagen Matrix Inc
15 Thornton Rd
Oakland NJ 07436-3115
For Additional Information Contact Peggy Hansen
201-405-1477 Ext. 304
Manufacturer Reason
for Recall		 The products may have been packaged with an incorrect Instructions for Use.
FDA Determined
Cause 2		 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 recalls@collagenmatrix.com 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = NPL and Original Applicant = COLLAGEN MATRIX, INC.
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