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.
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, Quantity: 65029 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, 210202
00643169063808, 00643169063815, 00643169063822, 00643169063839, 00643169063846, 00643169063853, 00643169063860, 00643169063877, 00643169063884, 00643169063891, 00643169063907
Official record: FDA (Device enforcement) ↗
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