Z-0410-2014 Class II Terminated
FDA device recall Z-0410-2014 was initiated by Synthes USA HQ, Inc. on Jul 30, 2013 and is designated Class II. 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. The recall status is terminated (terminated Apr 16, 2015). Affected quantity: 40.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 4, 2013
- Initiation Date
- Jul 30, 2013
- Termination Date
- Apr 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