Class 2 Device Recall Tytin Regular Set

• Date Initiated by Firm: May 29, 2014
• Date Posted: June 13, 2014
• Recall Status: Terminated on October 27, 2014
• Recall Number: Z-1788-2014
• Recall Event ID: 68426
• 510(K)Number: K951663
• Product Classification: Alloy, amalgam - Product Code EJJ
• 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.
• Code Information: Part Number 29948, Lot Number 3-1294. Expires October 2016
• FEI Number: 1815757
• Recalling Firm/ Manufacturer: Kerr Corporation; 28200 Wick Rd; Romulus MI 48174-2639
• Manufacturer 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 Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = EJJ