FDA Device recall Z-2207-2023
Durepair Dura Regeneration Matrix: DUREPAIR DURA SUBSTITUTE 2 X 2, 61100
- FDA Device
- Class II
- ongoing
- Published 2023-07-26
On 2023-07-26 the FDA classified a Class II recall of Durepair Dura Regeneration Matrix: DUREPAIR DURA SUBSTITUTE 2 X 2, 61100 by Medtronic Neurosurgery, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2207-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-06-13 |
| Published | 2023-07-26 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medtronic Neurosurgery |
| Distribution | US |
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
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.
Identifiers
| code_info | REF/Expiration Date On or Prior/UDI-DI/Lots: 61100/March 31, 2025/00643169063808/2006039, 2007020, 2009028, 2010001, 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, 2204016, 2204035, 2207014, 2207046; 61105/February 28, 2025/00643169063815/2009060, 2011017, 2102011, 2102027, 2102047, 2103002, 2104042, 2105029, 2108001, 2108012, 2108016, 2109023, 2110010, 2111021, 2111024, 2111046, 2112027, 2202034, 2203034, 2204027, 2206008, 2207015, 2207033; 61106/December 31, 2024/00643169063822/2010017, 2103003, 2105030, 2105038, 2108013, 2108018, 2109004, 2110011, 2110031, 2111025, 2202035, 220302; 61110/March 31, 2025/00643169063839/2006039, 2010018, 2101014, 2102002, 2102028, 2103004, 2105031, 2108019, 2109024, 2110012, 2111026, 2201005, 2202036, 2204025, 2204040; 61111/April 30, 2025/00643169063846/2008039, 2010019, 2102021, 2103005, 2105032, 2106004, 2108014, 2110013, 2111027, 2202037, 2203022, 2203028, 2 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2207-2023%22
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