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Class 2 Device Recall DuraMatrix Collagen Dura Substitute Membranes |
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Date Initiated by Firm |
December 13, 2021 |
Date Posted |
February 24, 2022 |
Recall Status1 |
Completed |
Recall Number |
Z-0669-2022 |
Recall Event ID |
89495 |
510(K)Number |
K061487
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Product Classification |
Dura substitute - Product Code GXQ
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Product |
RESODURA matrix onlay 10.0 cm x 12.5 cm - indicated as dural substitutes for the repair of dura matter.
REF: DUMO10125
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Code Information |
Lot Number 2107292022 Exp. Date: 7/31/2024
UDI: (01)00813954023267(17)240731(10)2107292022 (note: UDI edited 3/7/2022) |
Recalling Firm/ Manufacturer |
Collagen Matrix, Inc. 110 Commerce Dr Allendale NJ 07401-1622
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For Additional Information Contact |
SAME 201-405-1477
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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
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FDA Determined Cause 2 |
Nonconforming Material/Component |
Action |
On 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 Commerce |
10 units |
Distribution |
DuraMatrix-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 Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = GXQ and Original Applicant = COLLAGEN MATRIX, INC.
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