FDA Enforcement
Class II
Terminated
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
Recall: Z-1291-2015
·
Reported March 25, 2015
Enforcement
- Recall Number
- Z-1291-2015
- Event ID
- 70551
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Sybron Dental Specialties
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 25, 2015
- Initiation Date
- February 11, 2015
- Classification Date
- March 18, 2015
- Termination Date
- May 21, 2015
- Address
- 1717 W Collins Ave, Orange, CA, 92867-5422, United States
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
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.
Code Info
Part Number: 4513C or 4513-1. Lot Number: 2014030110
Distribution
Worldwide distribution. US Nationwide, Canada, Australia, Netherlands, Switzerland, Japan,
Quantity
172