DuraMatrix-Onlay Collagen Dura Substitute Membrane 4 inches x 5 inches (10.0cm x 12.5cm) REF: CDSLM45
Summary
The FDA issued a Class II for DuraMatrix-Onlay Collagen Dura Substitute Membrane 4 inches x 5 inches (10.0cm by Collagen Matrix, Inc.. Reason: Outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk of patient infection, which could lead to revision sur.
Details
Source
Device Recall
External ID
Z-0668-2022
Action Date
2022-03-02
Status
Terminated
Category
device
Product Description
DuraMatrix-Onlay Collagen Dura Substitute Membrane 4 inches x 5 inches (10.0cm x 12.5cm) REF: CDSLM45
Lot/Code Info: Model Number CDSLM45 Lot Number 2107292022 Exp Date:7/31/2024 UDI: (01)00813954020273(17)240731(10)2107292022
Quantity Affected: 68 units
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
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-12-13
Company
Allendale, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 122 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Collagen Matrix, Inc. has 11 FDA actions in our database, including 3 recalls and 8 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Collagen Matrix, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Collagen Matrix, Inc. have FDA actions?
Collagen Matrix, Inc. has 11 FDA actions in our database, including 3 recalls and 8 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0668-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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