FDAFDA · Food and drugs·Recall number Z-2530-2016
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).
Published August 24, 2016 · Recall initiated: June 24, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Danville Materials, Inc.
- Distributor
- US and New Zealand, Australia, Canada, Japan, Israel, United Kingdom, Italy, Mexico.
- Lot
- Part number 1008: Lot numbers: 1133; 1135; 1136; 1137; 1138; 1163; 1171; 1172; 1173; 1174; 1175; 1218; 1240; 1243; 1258; 1264; 1264-1; 1275; 1276; 1277; 1311; 1314; 1315; 1325; 1326.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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