Dentech Corp.: Medical Device Recall in 2021 - (Recall #: Z-1676-2021)

Rubber Dam Clamp, KSK - Product Usage: used for prevention of contamination by saliva and moisture prevention during dental treatment.

Class II

Removing parts for safety reasons due to possible breakage.

Product Code 01012912, no12A Lot Numbers: 190627004, 1812L014, 190708016, 190701018, 190712065, 190712043, 190805016, 190730025, 190731036, 190829013, 190903026, 190815021, 190925016, 191017004, 191009022, 191016040, 191025003, 190816010, 190816060, 191029047, 191016023, 191107029, 191114018, 191121025, 190625014, 191121004, 191029097, 191029138, 191029182, 191030018, 191210088, 200116011, 200204002, 200212011, 191206008, 191206065, 200214043, 200214025, 200225008, 200303006, 200311015, 200402007, 191029223, 191029266, 191029308, 200422023, 200526007, 200526026, 191206068, 191206122, 200130015, 191212035, 200619016, 191206073, 191029351, 200312010, 191206128, 201021075, 190507036, 190508005, 190522012, 190522064, 190524025, 190524061, 190528085, 190530037, 190603009, 190606002, 1806I002, 1808A006, 1810J009, 1812L014. Product Code 01014912, no 12A Lot Numbers: 190813028, 190731042, 190815020, 191113031, 191114017, 191030035, 200121009, 200214042, 200601023, 200619020, 200217009, 200731013, 201001091, 210118026, 210310033, 190614015, 190626011, 1805F039, 1806F049, 1810K008, 1812F024, 1903A003. Product Code 01019912, no 12A Lot Numbers: 191009021, 191114016, 191130036, 191030050, 200214041, 200601022, 200619026,190528052, 200902084, 210113041, 190401021, 190509164, 190513002, 190521029, 190524019, 190626076, 1805F055, 1806F058, 1809B013, 1810K012, 1812F027, 1903A004. Product Code 01012913, no 13A Lot Numbers: 190708017, 190712066, 190712044, 190805017, 190722009, 190730026, 190801003, 190731037, 190903027, 190815027, 190924002, 191002030, 191017005, 191009026, 191016041, 190816012, 190816060, 191029048, 191016024, 191107030, 191114023, 191121026, 191119018, 191121005, 191212036, 191029098, 191029139, 191029183, 191030019, 191210089, 200116012, 200212012, 191206011, 191206065, 200214048, 200214026, 200225009, 200303006, 200303007, 200311016, 200402008, 191029224, 191029267, 191029309, 200424019, 200422024, 200526008, 200526027, 191206068, 191206122, 200130016, 200623055, 200619047, 200617020, 200619017, 191206075, 200609040, 200312011, 200629014, 200723009, 200722013, 200727040, 200821033, 200727020, 191206129, 200626019, 200825074, 200825082, 191029478, 201006029, 201023047, 191206129, 201002057, 200923120, 201022031, 200924044, 201006052, 190508006, 190514013, 190522013, 190522065, 190524026, 190528091, 190530038, 190603010, 190606005, 1808A011, 1805H023, 1806I006, 1808A011, 1810G008, 1810J011, 1810J011, 1812L015. Product Code 01014913, no 13A Lot numbers: 190813029, 190731043, 190815026, 191114022, 191113032, 191130026, 191030036, 200214047, 200214031, 200601026, 200619021, 200731014, 201001096, 201113072, 210113045, 210118027, 210212048, 190614014, 190626012, 1806G005, 1810K009, 1812G003, 1902C003, 1902C003. Product Code 01019913, no 13A Lot numbers: 191009025, 191114021, 191030051, 200214035, 200619028, 200324042, 201002118, 201001097, 201113028, 201211159, 201211255, 190513003, 190521030, 190524020, 190626077, 1806G011, 1809A013, 1810K013, 1812G005, 1901G043, 1902F003. Product Code 01012026, no 26 Lot numbers: 1811J010, 190521007, 190705008, 190712051, 190726034, 190805022, 190709018, 190716045, 190813002, 190827085, 190925021, 191002026, 191009044, 191016044, 190816025, 191029050, 191115003, 191210023, 200105015, 191212045, 190916008, 190924034, 191206032, 191029101, 191029142, 191029186, 191030022, 191015131, 191112009, 191126043, 191210065, 191223018, 200114017, 200128016, 191206093, 200214074, 200225012, 191029227, 191029270, 191029312, 200325007, 200522006, 200526032, 200623058, 200430027, 200619054, 200622022, 200609032, 191029355, 200623028, 200312004,200722037, 200901033, 191029396, 191206142, 191206142, 200915054, 200728053, 200817108, 200916015, 191029440, 191029481, 200902058, 200914064, 201006030, 201022056, 201023048, 201002078, 200923123, 201009051, 191029524, 201028029, 200924047, 201002141, 201002168, 201002186, 201209001, 191029566, 201207039, 201014048. Product Code 01014026, no 26 Lot numbers: 190815048, 191114047, 191030039, 200214073, 200622076, 190613002, 190626019, 1807A026, 1807A026, 1811C001, 1812F019, 1901G007. Product Code 01019026, no26 Lot numbers: 191002038, 191009043, 190513001, 190626085, 1806G010, 1809B011, 1809F005, 1811C007, 1902F001.

Worldwide distribution - US Nationwide distribution in the states of CA, MN, KY, WA and the countries of Russia, Libya, Moldova, China, Egypt, India, Canada, Guatemala, Iraq, Saudi Araba, Australia, Ukraine, Israel, Indonesia, Malaysia, UK, Singapore, South Korea, Georgia, Taiwan Lithuania, Greece, Sweden, Netherland, France, Poland, Slovenia, Bulgaria, Norway and Romania.

Voluntary: Firm initiated