Class 2 Device Recall Perioscopy Sheath

• Date Initiated by Firm: June 24, 2016
• Create Date: August 12, 2016
• Recall Status: Terminated on December 09, 2016
• Recall Number: Z-2530-2016
• Recall Event ID: 74533
• 510(K)Number: K982480
• Product Classification: Unit, operative dental - Product Code EIA
• Product: Perioscopy Sheath: Part number: 1008; The Perioscopy Sheath is a single-use sterile component used with the Perioscopy System, which is a medical device that features miniaturized digital video technology, and enables the healthcare professional to see magnified details of the tooth anatomy and deposits below the gum line (i.e. calculus root fractures, restoration margins, tooth decay).
• Code Information: Part number 1008: Lot numbers: 1133; 1135; 1136; 1137; 1138; 1163; 1171; 1172; 1173; 1174; 1175; 1218; 1240; 1243; 1258; 1264; 1264-1; 1275; 1276; 1277; 1311; 1314; 1315; 1325; 1326.
• Recalling Firm/ Manufacturer: Danville Materials, Inc.; 3420 Fostoria Way Ste A200; San Ramon CA 94583-1327
• For Additional Information Contact: Craig Bruns; 925-973-0710 Ext. 202
• Manufacturer Reason for Recall: The Perioscopy Sheaths are currently provided with a label that indicates the Sheath has a 3 year shelf-life/expiry date. Danville Materials has become aware that validation data are not available to support the 3-year shelf-life/expiration dating claim.
• FDA Determined Cause: Under Investigation by firm
• Action: Recall letters were sent on June 24 to Distributor OEM and customers by traceable delivery method. Letters informed customers of the issue and the affect part and lot numbers. Pro duct is to be quarantined and returned. Distributors are instructed to contact all customers and provide a copy of the recall letter. The response form should be completed and returned by each consignee.
• Quantity in Commerce: ~ 2123 units
• Distribution: US and New Zealand, Australia, Canada, Japan, Israel, United Kingdom, Italy, Mexico.
• 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 = EIA