Reported Mar 2, 2022 · Terminated
RESODURA matrix onlay 10.0 cm x 12.5 cm - indicated as dural substitutes for the repair of dura matter. REF: DUMO10125
Collagen Matrix, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Collagen Matrix, Inc. · 110 Commerce Dr · Allendale, NJ · 07401-1622
Is this the product you have?
- RESODURA matrix onlay 10.0 cm x 12.5 cm - indicated as dural substitutes for the repair of dura matter
- REFDUMO10125
- Lot codes and dates
- Lot Number 2107292022 Exp
- Date7/31/2024
- UDI(01)00813954023267(17)240731(10)2107292022 (note: UDI edited 3/7/2022)
- Amount recalled
- 10 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk of patient infection, which could lead to revision surgery
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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