Recall Z-1788-2014 ยท EJJ Alloy, Amalgam
Kerr Corporation
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.
| Date | Jun 13, 2014 (initiated May 29, 2014) |
| Status | Terminated |
| Reason | 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. |
| 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 |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K951663 | TYTIN R Kerr Corporation (Danbury), Jun 6, 1995 |