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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 92514

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
June 13, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Medtronic Neurosurgery

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-2207-2023
Recall number
Z-2207-2023
Initiated
June 13, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Medtronic Neurosurgery
Quantity
65029

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
out-of-specification

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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, 2207016; 62100/January 31, 2025/00643169063853/2007021, 2008040, 2009026, 2009061, 2010014, 2011018, 2012001, 2101015, 2101020, 2102012, 2102022, 2102048, 2103019, 2104043, 2105033, 2106005, 2108020, 2109001, 2109020, 2109028, 2110014, 2110032, 2110033, 2111028, 2111035, 2111037, 2112001, 2112002, 2202038, 2203023, 2204001, 2204028, 2206013, 2206027, 2207017, 2207048, 2208009; 62105/January 31, 2025/00643169063860/2008005, 2008041, 2009029, 2010015, 2010020, 2012002, 2101016, 2102003, 2102013, 2102029, 2103006, 2103036, 2104044, 2105036, 2106035, 2108003, 2108015, 2109002, 2109003, 2110003, 2110015, 2110016, 2111022, 2111033, 2111047, 2201006, 2202014, 2202025, 2203015, 2203025, 2203031, 2204023, 2204036, 2204041, 2206014, 2206028, 2207018, 2207044; 62106/December 31, 2024/00643169063877/2008042, 2010021, 2101017, 2102023, 2103007, 2104045, 2105039, 2106007, 2108004, 2108021, 2109005, 2110017, 2110034, 2111029, 2202039, 2207019, 2207051; 62110/March 31, 2025/00643169063884/2006041, 2007022, 2008006, 2008043, 2010022, 2101009, 2101018, 2102026, 2102049, 2103020, 2104046, 2105001, 2105040, 2108005, 2108022, 2110004, 2110018, 2111036, 2201007, 2202015, 2202031, 2204017, 2204042, 2205031, 2205032, 2206007, 2207020, 2207049; 62111/May 31, 2025/00643169063891/2010023, 2012003, 2101019, 2102024, 2103008, 2105034, 2106009, 2108023, 2109006, 2110019, 2110035, 2111030, 2111034, 2202040, 2203024, 2204002, 2207021, 2207037, 2208027; 62158/April 30, 2025/00643169063907/2011019, 2103009, 2105035, 2110020, 2111031, 2202041, 2203033, 2204029, 2207006

Distribution pattern

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.

Field note

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