Reported Jul 26, 2023 · Ongoing
Durepair Dura Regeneration Matrix
Medtronic Neurosurgery
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: Medtronic Neurosurgery · 5290 California Ave · Irvine, CA · 92617-3073
Is this the product you have?
Durepair Dura Regeneration Matrix
11 of 11 products
| # | Product as published |
|---|---|
| 1 | DUREPAIR DURA SUBSTITUTE 2 X 2, 61100 |
| 2 | DUREPAIR DURA SUBSTITUTE 3 X 3, 61105 |
| 3 | DUREPAIR DURA SUBSTITUTE 1 X 3, 61106 |
| 4 | DUREPAIR DURA SUBSTITUTE 4 X 5, 61110 |
| 5 | DUREPAIR DURA SUBSTITUTE 1 X 1, 61111 |
| 6 | DURA 62100 SUBSTITUTE DUREPAIR 2X2IN NCE, 62100 |
| 7 | DURA 62105 SUBSTITUTE DUREPAIR 3X3IN NCE, 62105 |
| 8 | DURA 62106 SUBSTITUTE DUREPAIR 1X3IN NCE, 62106 |
| 9 | DURA 62110 SUBSTITUTE DUREPAIR 4X5IN NCE, 62110 |
| 10 | DURA 62111 SUBSTITUTE DUREPAIR 1X1IN NCE, 62111 |
| 11 | DURA 62158 SUBSTITUTE DUREPAIR 5X8IN NCE, 62158. |
- Lot codes and dates
11 of 11 products · 245 lot codes
Recalled lot codes, grouped by product number Date On or Prior UDI-DI / Lots 61100March 312025/00643169063808/20060392007020200902820100012010016210200121020202103001210502821060012108011210801721090222110009211003021110232111045211202622030202204016220403522070142207046
61105February 282025/00643169063815/20090602011017210201121020272102047210300221040422105029210800121080122108016210902321100102111021211102421110462112027220203422030342204027220600822070152207033
61106December 312024/00643169063822/20100172103003210503021050382108013210801821090042110011211003121110252202035220302
61110March 312025/00643169063839/200603920100182101014210200221020282103004210503121080192109024211001221110262201005220203622040252204040
61111April 302025/00643169063846/2008039201001921020212103005210503221060042108014211001321110272202037220302222030282207016
62100January 312025/00643169063853/2007021200804020090262009061201001420110182012001210101521010202102012210202221020482103019210404321050332106005210802021090012109020210902821100142110032211003321110282111035211103721120012112002220203822030232204001220402822060132206027220701722070482208009
62105January 312025/00643169063860/20080052008041200902920100152010020201200221010162102003210201321020292103006210303621040442105036210603521080032108015210900221090032110003211001521100162111022211103321110472201006220201422020252203015220302522030312204023220403622040412206014220602822070182207044
62106December 312024/00643169063877/20080422010021210101721020232103007210404521050392106007210800421080212109005211001721100342111029220203922070192207051
62110March 312025/00643169063884/2006041200702220080062008043201002221010092101018210202621020492103020210404621050012105040210800521080222110004211001821110362201007220201522020312204017220404222050312205032220600722070202207049
62111May 312025/00643169063891/2010023201200321010192102024210300821050342106009210802321090062110019211003521110302111034220204022030242204002220702122070372208027
- Amount recalled
- 65029
Where it was sold
Why it was recalled
Dura regeneration matrix may have out-of-specification endotoxin levels due to issues with in-process and finished goods endotoxin testing, which may present clinically with signs and symptoms of an acute inflammatory process, comparable to infection.
This product could cause temporary or reversible health problems — stop using it.
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