Medtronic Durepair Dura Matrix Recalled Due to Endotoxin Contamination
Medtronic is recalling Durepair Dura Regeneration Matrix surgical implants worldwide due to potential endotoxin contamination that may cause inflammation similar to infection.
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: FDA Class II medical device recall with a serious potential hazard—endotoxin contamination that may trigger inflammatory response comparable to infection. However, the source text does not report any illnesses or injuries, and the hazard is theoretical. Per the rubric, a score is at most 3 when illnesses are not reported and the hazard is theoretical.
Plain-English summary
Medtronic Neurosurgery is recalling Durepair Dura Regeneration Matrix surgical implants in multiple sizes. Approximately 65,029 units have been distributed worldwide across all U.S. states and numerous other countries.
The implants may contain out-of-specification endotoxin levels due to problems with in-process and finished goods testing procedures. Endotoxin can cause signs and symptoms of an acute inflammatory process comparable to infection.
The recall affects implants manufactured with various lot numbers, with expiration dates extending to May 2025. Anyone who has received these implants should contact their healthcare provider with questions about the recall and their individual situation.
The recalled product
- Product
- Durepair Dura Regeneration Matrix: DUREPAIR DURA SUBSTITUTE 2 X 2, 61100; DUREPAIR DURA SUBSTITUTE 3 X 3, 61105; DUREPAIR DURA SUBSTITUTE 1 X 3, 61106; DUREPAIR DURA SUBSTITUTE 4 X 5, 61110; DUREPAIR DURA SUBSTITUTE 1 X 1, 61111; DURA 62100 SUBSTITUTE DUREPAIR 2X2IN NCE, 6
- Manufacturer
- Medtronic Neurosurgery
- Hazard
- endotoxin
- inflammatory-response
- infection-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- REF/Expiration Date On or Prior/UDI-DI/Lots: 61100/March 31
- 2025/00643169063808/2006039
- 2007020
- 2009028
- 2010001
- 2010016
- 2102001
- 2102020
- 2103001
- 2105028
- 2106001
- 2108011
- 2108017
- 2109022
- 2110009
- 2110030
- 2111023
- 2111045
- 2112026
- 2203020
Distribution
Distributed nationwide across the United States.
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