Gluma Desensitizer Power Gel Product Usage: Usage: This is a class 2 medical device. For reduction or elimination of pain in exposed cervical areas that do not require restoration. It is also used for alleviation or reduction of dentinal sensitivity after preparation of teeth to receive fixed prosthesis or restorations.
Enforcement
- Recall Number
- Z-1651-2014
- Event ID
- 68223
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Heraeus Kulzer, LLC.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 28, 2014
- Initiation Date
- April 23, 2014
- Classification Date
- May 22, 2014
- Termination Date
- November 5, 2014
- Address
- 300 Heraeus Dr, N/A, South Bend, IN, 46614-2557, United States
Description
Gluma Desensitizer Power Gel Product Usage: Usage: This is a class 2 medical device. For reduction or elimination of pain in exposed cervical areas that do not require restoration. It is also used for alleviation or reduction of dentinal sensitivity after preparation of teeth to receive fixed prosthesis or restorations.
The firm discovered that the Gluma Desensitizer Power Gel can be inadvertently extruded from the application syringe all at once when it is supposed to extrude on the desired area a small amount at a time. If extruded all at once, product could reach the dental patients mucosa, face or eyes or the dental professional could be exposed. This would cause irritation, burning or blistering.
Model Number(s): 66043451 Expiry: 2015-09 Syringe Lot number 010103, which are contained within Kit lot numbers 42.43.44.45.46.47.48.49,50, and 51. Note; lots 49 and 50 were captured in house, 0 was distributed. Lot 51 was made by the manufacturer, however, never received by us or distributed.
US Nationwide Distribution in the states of GA, TX, IL, CA, WA, WI, HI, MO, FL, NJ, TN, PA, NY, NC, OH, IN, CT, KY, AZ, NV, IA,
5,112 syringes or 1,278 kits (1 Kit=4 syringes)