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

FDA device recall Z-0410-2014 · posted 2013-11-27 · Terminated

Recall details

Recalling firm

Synthes USA HQ, Inc.

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.

Action taken

Synthes sent an Urgent Notice: Medical Device Notification letter dated October 8, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to returny any of the affect devices, call Synthes at 1-800-479-6329 to obtain a Return Authorization Number, complete the Verification Section indicating the affected product has been located, also indicate the number of devices found and note the Return Authorization Number. Return the Verification Form to: Credit/Returns Synthes 1101 Synthes Avenue Monument, CO 80132 Customers were also instructed to return the Verification Section even if they don't have the affected product. Customers with questions were instructed to call 610-719-5450 or contact their Synthes Sales Consultant. For questions regarding this recall call 610-719-5000.

Root cause

Incorrect or no expiration date

Status

Terminated

Product code

OAR

Quantity affected

40

Distribution

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

Date initiated

2013-07-30

Date posted

2013-11-27

Date terminated

2015-04-16

Location

West Chester, PA