Collagen Dura Substitute Membrane Recalled for Compromised Sterility
Collagen Matrix is recalling 68 units of DuraMatrix-Onlay Collagen Dura Substitute Membrane due to unsealed outer packaging that may compromise product sterility and increase infection risk.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving a risk-of-harm product (surgical membrane) with no reported injuries or illnesses at this time. The compromised sterility presents a potential infection risk, meeting the criteria for High severity as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Collagen Matrix, Inc. is recalling 68 units of the DuraMatrix-Onlay Collagen Dura Substitute Membrane (Reference: CDSLM45) in the 4 inches x 5 inches (10.0cm x 12.5cm) size. The affected lot number is 2107292022 with an expiration date of July 31, 2024.
The outer packaging (outer pouch) of the affected units is not sealed, which compromises the product's sterility. This creates a potential risk of patient infection that could lead to revision surgery.
The recalled devices were distributed nationwide in the United States (including Florida and Indiana), Puerto Rico, Canada, Chile, and Colombia. The RESODURA matrix onlay version was also distributed in Germany.
Healthcare facilities and users who have received affected units should verify the lot number and expiration date against the information above. If you possess these recalled units, contact Collagen Matrix, Inc. for instructions on return or disposal. Do not use affected product.
The recalled product
- Product
- DuraMatrix-Onlay Collagen Dura Substitute Membrane 4 inches x 5 inches (10.0cm x 12.5cm) REF: CDSLM45
- Manufacturer
- Collagen Matrix, Inc.
- Hazard
- unsealed-packaging
- sterility-compromise
- infection-risk
Distribution
Distributed nationwide across the United States.
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