Lower riskMedical device recall · FDA · Published December 13, 2021
Collagen Matrix DuraMatrix-Onlay Membrane Recall: Infection Risk from Unsealed Packaging
Collagen Matrix recalls DuraMatrix-Onlay collagen membrane (4x5 inches) due to unsealed outer pouch risking patient infection. Affected units have specific lot/expiry dates. Contact for return instructions.
Outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk of patient infection, which could lead to revision surgery
Take action
Contact the company
📍Recalling firmCollagen Matrix, Inc.110 Commerce Dr · Allendale, NJ 07401-1622
“Collagen Matrix DuraMatrix-Onlay Membrane Recall: Infection Risk from Unsealed Packaging.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61435-collagen-matrix-duramatrix-onlay-membrane-recall-infection-risk-from-unsealed. Based on FDA recall #Z-0668-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0668-2022%22&limit=1).
The FDA announced on Dec. 13, 2021, that Collagen Matrix Inc. is recalling DuraMatrix-Onlay Collagen Dura Substitute Membrane because the outer pouch is not sealed, compromising sterility and posing a risk of patient infection. The recall involves 68 units distributed in the U.S., Canada, Chile, Colombia, and Germany.
How to tell if you have it
Brand: Collagen Matrix
Product: DuraMatrix-Onlay Collagen Dura Substitute Membrane 4 inches x 5 inches (10.0cm x 12.5cm)
REF: CDSLM45
Model Number: CDSLM45
Lot Number: 2107292022
Expiration Date: 7/31/2024
UPC: 00813954020273
The hazard
The outer packaging (outer pouch) is not sealed, which compromises sterility and results in a potential risk of patient infection that could lead to revision surgery.
Context
GovInfoNow's records show Collagen Matrix Inc. has had five other recalls since Aug. 16, 2018, including a 2022-08-03 recall for unsealed packaging and a 2019-11-05 recall for incorrect instructions. Other recent recalls of similar products include Medline Convenience Kits Recall: Risk of Sterile Packaging Breach (2026-06-12) and Medline Blood Culture Kits Recall: Risk of Sterile Packaging Breach (2026-06-12).
How to tell if you have this one
Check for the product name 'DuraMatrix-Onlay Collagen Dura Substitute Membrane' with size 4 inches x 5 inches (10.0cm x 12.5cm). Look for lot number 2107292022 and expiration date 7/31/2024 on the packaging.
Brand
Collagen Matrix
Product
Collagen Matrix, Inc. recalls DuraMatrix-Onlay Collagen Dura Substitute Membrane 4 inches x 5 inches (10.0cm x 12.5cm) REF: CDSLM45
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
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.
Recall number
Product, codes & lots
Quantity
Z-0668-2022
DuraMatrix-Onlay Collagen Dura Substitute Membrane 4 inches x 5 inches (10.0cm x 12.5cm) REF: CDSLM45; Model Number CDSLM45 Lot Number 2107292022 Exp Date:7/31/2024 UDI: (01)00813954020273(17)240731(10)2107292022
68 units
Z-0669-2022
RESODURA matrix onlay 10.0 cm x 12.5 cm - indicated as dural substitutes for the repair of dura matter. REF: DUMO10125; Lot Number 2107292022 Exp. Date: 7/31/2024 UDI: (01)00813954023267(17)240731(10)2107292022 (note: UDI edited 3/7/2022)
10 units
Based on the official FDA remedy
What to do — step by step
Check Product Details
Identify the product by its size (4x5 inches), lot number (2107292022), and expiration date (7/31/2024) on the packaging.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 2 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Florida, Indiana, Puerto Rico.
Recall timeline
FDA terminated this recall 2.8 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0668-2022 (December 13, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0668-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.