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Recall Observatory FDA recall evidence

Device product

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

Z-1676-2021

April 21, 2021

Class II

Product summary

Firm
Dentech Corp.
Event
Event 87847
Status
Terminated
Classification
Class II
Quantity
87,842 UNITS
Official record key
device-enforcement:Z-1676-2021

Official wording

Reason: Removing parts for safety reasons due to possible breakage.

Code information: 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.

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Removing parts for safety reasons due to possible breakage.