# FDA recall Z-2207-2023

> **Medtronic Neurosurgery** · Class II · device recall initiated 2023-06-13.

## 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.

## Distribution

Worldwide - US Nationwide distribution including in the states of PR, TX, WA, HI, MI, GA, AL, IL, IN, IA, MO, KY, NY, CA, AZ, PA, UT, ME, MD, MN, FL, AK, NE, VA, OR, WI, NC, LA, SD, TN, MS, DE, NJ, ID, SC, OH, MA, DC, NM, WV, NH, CT, NV, OK, AR, KS, MT, RI, CO, ND, WY, VT and the countries of Barbados, Cayman Islands, Honduras, Belgium, Switzerland, Italy, United Kingdom, Canary Islands, Hungary, Poland, Germany, Spain, Czech Republic, Thailand, South Africa, Greece, Finland, Portugal, Colombia, Norway, Iraq, Jordan, Estonia, Austria, Slovakia, Libya, Qatar, Bosnia And Herzegovina, Algeria, Dominican Republic, Canada, Australia, New Zealand, Sweden, El Salvador, Ireland, United Arab Emirates, Saudi Arabia, Kazakhstan, Turkey, Mauritius, Ghana, Russian Federation, Lebanon, Romania, Iran, Islamic Republic Of, Egypt, Namibia, Senegal, Ecuador, Panama, Peru, Guyana, Mexico, Chile, Costa Rica, Viet Nam, Kuwait, Ukraine, Israel, Turkmenistan.

## Key facts

- **Recall number:** Z-2207-2023
- **Recalling firm:** Medtronic Neurosurgery
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-06-13
- **Report date:** 2023-07-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Irvine, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2207-2023

## Citation

> AI Analytics. FDA recall Z-2207-2023. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-2207-2023. Source: US FDA. Licensed CC0.

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