Z-2530-2016Class II

Perioscopy Sheath: Part number: 1008; The Perioscopy Sheath is a single-use sterile component used with the...

Name: Z-2530-2016 Perioscopy Sheath: Part number: 1008; The Perioscopy Sheath is a single-use sterile component used with the...
Creator: Danville Materials, Inc.
Published: 2016-06-24
License: https://open.fda.gov/license/

Danville Materials, Inc. / initiated 2016-06-24 / Terminated / root cause: labeling and UDI

FDA source

Danville Materials, Inc. began a recall of 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... on 2016-06-24. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2530-2016
Classification: Class II
Status: Terminated
Initiated: 2016-06-24
Posted: 2016-08-12
Terminated: 2016-12-09
Recalling firm: 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).
Product code: EIA Unit, Operative Dental
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.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: ~ 2123 units
Distribution: US and New Zealand, Australia, Canada, Japan, Israel, United Kingdom, Italy, Mexico.
Product 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2530-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2530-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-24	2016-08-12

Product code EIA

K982480Class IPerioview Model Dv-1 Fiberscope and Window Sheath.Dentalview, Inc. / cleared 1998-09-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)