Z-1788-2014Class II

Tytin Regular Set, Double Spill, 50 Capsules, Part Number 29948, Lot Number 3-1294. The intended use of this...

Name: Z-1788-2014 Tytin Regular Set, Double Spill, 50 Capsules, Part Number 29948, Lot Number 3-1294. The intended use of this...
Creator: Kerr Corporation
Published: 2014-05-29
License: https://open.fda.gov/license/

Kerr Corporation / initiated 2014-05-29 / Terminated

FDA source

Kerr Corporation began a recall of Tytin Regular Set, Double Spill, 50 Capsules, Part Number 29948, Lot Number 3-1294. The intended use of this device is to be used as a dental restorative... on 2014-05-29. FDA classified it as Class II and gives the reason as "Kerr Corporation is recalling one (1) lot of Tytin Regular Set ( Part Number 29948, Lot Number 3-1294), because it may set faster than specified in the Directions for Use". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1788-2014
Classification: Class II
Status: Terminated
Initiated: 2014-05-29
Posted: 2014-06-13
Terminated: 2014-10-27
Recalling firm: Kerr Corporation
Product: Tytin Regular Set, Double Spill, 50 Capsules, Part Number 29948, Lot Number 3-1294. The intended use of this device is to be used as a dental restorative material in the treatment of dental caries.
Product code: EJJ Alloy, Amalgam
Reason for recall: Kerr Corporation is recalling one (1) lot of Tytin Regular Set ( Part Number 29948, Lot Number 3-1294), because it may set faster than specified in the Directions for Use.
FDA root cause: Unknown/Undetermined by firm
Action: Kerr Corporation initiated this recall by sending the recall notification letter accompanied by a return form, to customers via USPS 1st class mail. The consignees are instructed to complete the return form and return any affected product to Kerr Corporation. The recall notification letter, dated May 29, 2014, titled "URGENT: MEDICAL DEVICE RECALL", informed customers of the recall by providing the following information: product description with part number and lot number, distribution date range, reason for recall, risk statement, instructions to customers and/or Kerr distributor on what to do with the recalled product, FDA MEDWATCH reporting system info, and company contact information, and instructed customers to complete the return form titled "Acknowledgement and Recall Return Form".
Quantity in commerce: 2,030 units
Distribution: Worldwide Distribution-USA (nationwide) and the countries of Canada, Mexico, Australia, Belgium, Czech Republic, Germany, Spain, France, Great Britain, French Guiana, Italy, Portugal, and Saudi Arabia.
Product codes and lots: Part Number 29948, Lot Number 3-1294. Expires October 2016

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1788-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1788-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-25	2014-06-13

Product code EJJ

K951663Class IITytin RKerr Corporation (Danbury) / cleared 1995-06-06

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)