Danville Materials, Inc.: Medical Device Recall in 2016 - (Recall #: Z-2530-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product 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).

Product Classification:

Class II

Date Initiated: June 24, 2016

Date Posted: August 24, 2016

Recall Number: Z-2530-2016

Event ID: 74533

Reason for Recall:

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.

Status: Terminated

Product Quantity: ~ 2123 units

Code Information:

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.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated