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U.S. Department of Health and Human Services

Class 2 Device Recall Matrix Neuro Screwdriver Blade MQC/MR Conditional/Short

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 Class 2 Device Recall Matrix Neuro Screwdriver Blade MQC/MR Conditional/Shortsee related information
Date Initiated by FirmMay 31, 2016
Date PostedJuly 12, 2016
Recall Status1 Terminated 3 on February 02, 2017
Recall NumberZ-2195-2016
Recall Event ID 74416
Product Classification Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment - Product Code HWE
ProductPart # 313.212, 1.3mm Stardrive Screwdriver Bld Slf-Retain Med/60mm MQC, Lot # 4363780, mfg. 9/18/2002 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.
Code Information Part # 313.212, 1.3mm Stardrive Screwdriver Bld Slf-Retain Med/60mm MQC, Lot # 4363780, mfg. 9/18/2002
Recalling Firm/
Manufacturer
Synthes (USA) Products LLC
1301 Goshen Pkwy
West Chester PA 19380-5986
For Additional Information ContactAnne Brisson
610-719-5443
Manufacturer 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.
FDA Determined
Cause 2
Labeling False and Misleading
ActionDePuy 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.
Quantity in Commerce34 units
DistributionUS 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.
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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