Perioscopy Sheath: Part number: 1008…

Date

Aug. 24, 2016

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Terminated

Filed by

Danville Materials, Inc.

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).

Reason

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.

Distribution pattern

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

Quantity

~ 2123 units

Codes and lots

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.

Recall started

June 24, 2016

Device type

Unit, Operative Dental

Root cause (FDA)

Under Investigation by firm

What the company told customers

Recall letters were sent on June 24 to Distributor OEM and customers by traceable delivery method. Letters informed customers of the issue and the affect part and lot numbers. Pro duct is to be quarantined and returned. Distributors are instructed to contact all customers and provide a copy of the recall letter. The response form should be completed and returned by each consignee.

Recall number

Z-2530-2016

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-2530-2016. The agency record governs; check it and the company before acting.