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U.S. Department of Health and Human Services

Class 2 Device Recall DuraMatrix Collagen Dura Substitute Membranes

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 Class 2 Device Recall DuraMatrix Collagen Dura Substitute Membranessee related information
Date Initiated by FirmDecember 13, 2021
Date PostedFebruary 24, 2022
Recall Status1 Terminated 3 on September 18, 2024
Recall NumberZ-0668-2022
Recall Event ID 89495
510(K)NumberK061487 
Product Classification Dura substitute - Product Code GXQ
ProductDuraMatrix-Onlay Collagen Dura Substitute Membrane 4 inches x 5 inches (10.0cm x 12.5cm) REF: CDSLM45
Code Information Model Number CDSLM45 Lot Number 2107292022 Exp Date:7/31/2024 UDI: (01)00813954020273(17)240731(10)2107292022
Recalling Firm/
Manufacturer		 Collagen Matrix, Inc.
110 Commerce Dr
Allendale NJ 07401-1622
For Additional Information ContactSAME
201-405-1477
Manufacturer Reason
for Recall		Outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk of patient infection, which could lead to revision surgery
FDA Determined
Cause 2		Nonconforming Material/Component
ActionOn Monday, December 6, 2021, Collagen Matrix Inc began informing the distributors (initial consignees) to place the lot in question on ship hold. On Monday, December 13, 2021, Collagen Matrix began issuing Urgent Medical Device Recall Notice letter to distributors via email. Letter states reason for recall, health risk and action to take: Check your inventory and that of your sub-distributors if applicable to determine if any of the affected product remains in stock and segregate all affected units from your inventory for return. Complete the 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, Collagen Matrix will ship replacement product and a prepaid return shipping label will be provided with further instructions for returning product that remains in your possession return the concerned products. If you have any questions after reviewing this notice, please call 201-405-1477, ext. 303 between 8:00am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a prompt to leave a voicemail
Quantity in Commerce68 units
DistributionDuraMatrix-Onlay distributed US Nationwide in the states of FL, IN, Puerto Rico, and the countries of Canada, Chile, and Colombia. RESODURA matrix onlay distributed in Germany.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = GXQ
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