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).
Enforcement
- Recall Number
- Z-2530-2016
- Event ID
- 74533
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Danville Materials, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 24, 2016
- Initiation Date
- June 24, 2016
- Classification Date
- August 12, 2016
- Termination Date
- December 9, 2016
- Address
- 3420 Fostoria Way Ste A200, N/A, San Ramon, CA, 94583-1327, United States
Description
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).
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.
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.
US and New Zealand, Australia, Canada, Japan, Israel, United Kingdom, Italy, Mexico.
~ 2123 units