Danville Materials, Inc. recalls Perioscopy Sheath: Part number: 1008; The Perioscopy Sheath is a single-use sterile component used with the Perioscopy…

Recall date

June 24, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2530-2016

FDA classification

Class II

Brand / firm

Danville Materials, Inc.

Sold / distributed

US and New Zealand, Australia, Canada, Japan, Israel, United Kingdom, Italy, Mexico.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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).