Durepair Dura Regeneration Matrix: DUREPAIR DURA SUBSTITUTE 2 X 2, 61100; DUREPAIR DURA SUBSTITUTE 3 X 3, 61105; DUR
Summary
The FDA issued a Class II for Durepair Dura Regeneration Matrix: DUREPAIR DURA SUBSTITUTE 2 X 2, 61100; DUR by Medtronic Neurosurgery. Reason: Dura regeneration matrix may have out-of-specification endotoxin levels due to issues with in-process and finished goods endotoxin testing, which may .
Details
Source
Device Recall
External ID
Z-2207-2023
Action Date
2023-07-26
Status
Ongoing
Category
device
Product Description
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.
Lot/Code Info: 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
Quantity Affected: 65029
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-06-13
Company
Irvine, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 192 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Medtronic Neurosurgery has 12 FDA actions in our database, including 9 recalls and 3 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medtronic Neurosurgery) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medtronic Neurosurgery have FDA actions?
Medtronic Neurosurgery has 12 FDA actions in our database, including 9 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2207-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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