Reported Aug 24, 2016 · Terminated
Perioscopy Sheath: Part number: 1008; The Perioscopy Sheath is a single-use sterile component used with the Perioscopy…
Danville Materials, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Danville Materials, Inc. · 3420 Fostoria Way Ste A200 · San Ramon, CA · 94583-1327
Is this the product you have?
- Perioscopy SheathPart
- number1008; 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)
- Lot codes and dates
- Part number 1008Lot
- numbers
11331135113611371138116311711172117311741175121812401243125812641264-112751276127713111314131513251326
- Amount recalled
- ~ 2123 units
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.
This product could cause temporary or reversible health problems — stop using it.
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