RESODURA Matrix Onlay Recalled Due to Unsealed Packaging
Collagen Matrix is recalling RESODURA matrix onlay dural substitutes due to outer packaging that is not properly sealed, potentially compromising sterility and creating a risk of infection.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 medical device used in brain surgery where compromised packaging creates a theoretical but significant risk of infection in an implanted device. No infections or injuries have been reported, placing this at Score 3 per the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Collagen Matrix, Inc. is recalling RESODURA matrix onlay 10.0 cm x 12.5 cm dural substitutes (model reference DUMO10125) used to repair the dura mater during neurosurgery.
The outer packaging (outer pouch) on affected units is not properly sealed. This compromised packaging compromises the sterility of the device. If the device becomes contaminated, patients who receive the implant could develop an infection at the surgical site, potentially requiring additional revision surgery.
The recall affects lot number 2107292022 (with expiration date July 31, 2024). The affected devices were distributed nationwide in Florida and Indiana, as well as to Puerto Rico, Canada, Chile, Colombia, and Germany. Ten units were affected.
Patients who have received this implant should consult their healthcare provider if they experience symptoms such as fever, wound drainage, or other signs of infection. Healthcare providers should check their inventory for affected lot numbers and handle the recalled devices according to their facility protocols.
The recalled product
- Product
- RESODURA matrix onlay 10.0 cm x 12.5 cm - indicated as dural substitutes for the repair of dura matter. REF: DUMO10125
- Manufacturer
- Collagen Matrix, Inc.
- Hazard
- Affected units
- 10
Distribution
Part of a larger recall action
This product is one of 2 recalled by Collagen Matrix, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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