Z-0410-2014 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 4, 2013
- Initiation Date
- July 30, 2013
- Termination Date
- April 16, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 40
Product Description
Vertebroplasty Needle Kit 10g Diamond Tip Intended to be used to inject PMMA cement into vertebral bodies during Vertebroplasty procedure.
Reason for Recall
Complaints were received of inconsistencies in the expiration dates shown on the packaging of the Vertebroplasty Needle Kit 10g Diamond Tip device.
Distribution Pattern
Nationwide Distribution including IN, MT, HI, and FL.
Code Information
Part No. 03.702.218S, Lot No. AJM838X