Device product

Vertebroplasty Needle Kit 10g Diamond Tip Intended to be used to inject PMMA cement into vertebral bodies during Vertebroplasty procedure.

Z-0410-2014

July 30, 2013

Class II

Product summary

Firm: Synthes USA HQ, Inc.
Event: Event 66414
Status: Terminated
Classification: Class II
Quantity: 40
Official record key: device-enforcement:Z-0410-2014

Official wording

Reason: Complaints were received of inconsistencies in the expiration dates shown on the packaging of the Vertebroplasty Needle Kit 10g Diamond Tip device.

Code information: Part No. 03.702.218S, Lot No. AJM838X

Distribution pattern: Nationwide Distribution including IN, MT, HI, and FL.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Complaints were received of inconsistencies in the expiration dates shown on the packaging of the Vertebroplasty Needle Kit 10g Diamond Tip device.