Durepair Dura Regeneration Matrix: DUREPAIR DURA SUBSTITUTE 2 X 2 — Class II medical device recall Z-2207-2023
Ongoing recall by Medtronic Neurosurgery, reported 2023-07-26, distributed nationwide. Dura regeneration matrix may have out-of-specification endotoxin levels due to issues with in-process and fini
| Recall number | Z-2207-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Neurosurgery, Irvine, CA, United States |
| Recall initiated | 2023-06-13 |
| Classified | 2023-07-20 |
| Reported by FDA | 2023-07-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BB, BE, CA, CH, CL, CO, CR, CZ, DE, DO, DZ, EC, EE, EG, ES, FI, GB, GH, GR, GY, HN, HU, IE, IL, IQ, IR, IT, JO, KW, KY, LB, MX, NO, NZ, PA, PE, PL, PT, QA, RO, SA, SE, SK, SV, TH, TR, UA, VN, ZA |
| Quantity | 65,029 |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00643169063808, 00643169063815, 00643169063822, 00643169063839, 00643169063846, 00643169063853, 00643169063860, 00643169063877, 00643169063884, 00643169063891, 00643169063907 |
| Lot numbers | 00643169063808/2006039, 00643169063815/2009060, 00643169063822/2010017, 00643169063839/2006039, 00643169063846/2008039, 00643169063853/2007021, 00643169063860/2008005, 00643169063877/2008042, 00643169063884/2006041, 00643169063891/2010023, 00643169063907/2011019, 2007020, 2007022, 2008006, 2008040, 2008041, 2008043, 2009026, 2009028, 2009029, 2009061, 2010001, 2010014, 2010015, 2010016, 2010018, 2010019, 2010020, 2010021, 2010022, 2011017, 2011018, 2012001, 2012002, 2012003, 2101009, 2101014, 2101015, 2101016, 2101017 and 205 more |
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, 62100; DURA 62105 SUBSTITUTE DUREPAIR 3X3IN NCE, 62105; DURA 62106 SUBSTITUTE DUREPAIR 1X3IN NCE, 62106; DURA 62110 SUBSTITUTE DUREPAIR 4X5IN NCE, 62110; DURA 62111 SUBSTITUTE DUREPAIR 1X1IN NCE, 62111; DURA 62158 SUBSTITUTE DUREPAIR 5X8IN NCE, 62158.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2207-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.