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Danville Materials, Inc. recalls Perioscopy Sheath: Part number: 1008; The Perioscopy Sheath is a single-use sterile component used with the Peri
Recalled August 24, 2016 · FDA recall Z-2530-2016 · Danville Materials
Hazard
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 Class II
Units
~ 2123 units
Sold at
US and New Zealand, Australia, Canada, Japan, Israel, United Kingdom, Italy, Mexico.
Description
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.
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).
Manufacturer(s)
Danville Materials, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →