Durepair Dura Regeneration Matrix: DUREPAIR DURA recall: Endotoxin
Durepair Dura Regeneration Matrix: DUREPAIR DURA SUBSTITUTE 2 X 2, 61100; DUREPAIR DURA SUBSTITUTE 3 X 3, 61105; DUREPAIR DURA SUBSTITUTE 1 X 3…
Why was Durepair Dura Regeneration Matrix: DUREPAIR DURA recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- 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…
- Recalling firm
- Medtronic Neurosurgery
- Quantity
- 65029
- 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.
- Recall date
- July 26, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)