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.
Recall
- Recall Number
- Z-1788-2014
- Event Number
- 68426
- Firm
- Kerr Corporation
- FEI Number
- 1815757
- Product Code
- EJJ
- Status
- Terminated
- Root Cause
- Unknown/Undetermined by firm
- Initiated
- May 29, 2014
- Posted
- June 13, 2014
- Terminated
- October 27, 2014
- Address
- 28200 Wick Rd, Romulus, MI, 48174-2639
Description
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.
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.
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".
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.
2,030 units