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).
FDA Recall Z-2530-2016 · Posted None
Recalling FirmDanville Materials, Inc.
Recall StatusTerminated
Product CodeEIA
Date Initiated2016-06-24
Date Terminated2016-12-09
Product Quantity~ 2123 units
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.
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.
Root Cause
Under Investigation by firm
Distribution Pattern
US and New Zealand, Australia, Canada, Japan, Israel, United Kingdom, Italy, Mexico.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.