Z-1676-2021Class II

Rubber Dam Clamp, KSK -

Name: Z-1676-2021 Rubber Dam Clamp, KSK -
Creator: Dentech Corp.
Published: 2021-04-21
License: https://open.fda.gov/license/

Dentech Corp. / initiated 2021-04-21 / Terminated / root cause: design

FDA source

Dentech Corp. began a recall of Rubber Dam Clamp, KSK - Product Usage: used for prevention of contamination by saliva and moisture prevention during dental treatment on 2021-04-21. FDA classified it as Class II and gives the reason as "Removing parts for safety reasons due to possible breakage". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1676-2021
Classification: Class II
Status: Terminated
Initiated: 2021-04-21
Posted: 2021-05-25
Terminated: 2023-01-12
Recalling firm: Dentech Corp.
Product: Rubber Dam Clamp, KSK - Product Usage: used for prevention of contamination by saliva and moisture prevention during dental treatment.
Product code: EEF Clamp, Rubber Dam
Reason for recall: Removing parts for safety reasons due to possible breakage.
Root cause tag: design
FDA root cause: Component design/selection
Action: On 04/21/21 the firm sent an email to its distributors with the following instructions: 1. Please identify the products first by "Lot No", "Product Code", Shipment date" and stop using and selling those items. 2.Inform DENTECH of total quantity of defective products. We will replace all of them free of charge once available. 3. Please return affected product to Dentech.
Quantity in commerce: 87,842 UNITS
Distribution: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1676-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1676-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-02	2021-05-25

Product code EEF

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)