Recall Z-2530-2016 ยท EIA Unit, Operative Dental
Danville Materials, Inc.
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).
| Date | Jun 24, 2016 |
| Status | Terminated |
| Reason | 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. |
| Root 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 | ~ 2123 units |
| Distribution | US and New Zealand, Australia, Canada, Japan, Israel, United Kingdom, Italy, Mexico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K982480 | PERIOVIEW MODEL DV-1 FIBERSCOPE AND WINDOW SHEATH. Dentalview, Inc., Sep 15, 1998 |