Home / Recalls / Sybron Dental Specialties / Z-1291-2015

Z-1291-2015 Class II Terminated

Recalled by Sybron Dental Specialties — Orange, CA

Recall Details

Product Type: Devices
Report Date: March 25, 2015
Initiation Date: February 11, 2015
Termination Date: May 21, 2015
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 172

Product Description

Outer cardboard box labeling: Pinnacle Cure Sleeve, Curing Light Tip Sleeves. Kerr Total Care. Part Number: 4513C or 4513-1 Single Patient Use Fits 13mm Tips. Pack of 400. Metrex Research, Manufacturer. Inner individual packaging of each sleeve: Cure Sleeve by Pinnacle Model 4500

Reason for Recall

Cases of Cure Sleeve labeled with part number 4513, which fits 13mm tips, have inner boxes labeled with part number 4500 which fit 7mm and 8mm tips. There is a low risk associated with the use of the product as the sleeve may tear causing a potential for cross contamination.

Distribution Pattern

Worldwide distribution. US Nationwide, Canada, Australia, Netherlands, Switzerland, Japan,

Code Information

Part Number: 4513C or 4513-1. Lot Number: 2014030110