Part # 313.946, Low Profile Neuro Screwdriver Blade/MR Safe/MQC/56mm Medium, Lot # 5053374, mfg 7/27/2005 Product Usage:

FDA device recall Z-2190-2016 · posted 2016-07-12 · Terminated

Recall details

Recalling firm

Synthes (USA) Products LLC

Reason for recall

DePuy Synthes is voluntarily initiating this recall due to affected devices that were distributed, etched and or labeled with MR Safety information not meeting the current ASTM standard.

Action taken

DePuy Synthes mailed an URGENT MEDICAL DEVICE FIELD SAFETY NOTIFICATION letter to their customers (Hospital Personnel, including Imaging Department Personnel and DePuy Synthes Colleague) to inform them of the recall and actions to take. The letter identified the affected, problem and actions to be taken. The letter instructed customers not to use the affected Instruments which are labeled or etched MR Safe and MR Conditional during MRI scans. Customers were asked to review the information contained in the Field Safety Notification letter and complete the Verification Section located on page 3 of this notification. For questions call 610-719-5450 or contact your DePuy Synthes Sales Consultant.

Root cause

Labeling False and Misleading

Status

Terminated

Product code

HWE

Quantity affected

26 units

Distribution

US Nationwide Distribution in the states of: AR,CA,CO,CT,DC,ID,IL,KY,LA,MA,MD,MN,MO,MS,MT,NY,PA and TX.

Date initiated

2016-05-31

Date posted

2016-07-12

Date terminated

2017-02-02

Location

West Chester, PA