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Recall Observatory FDA recall evidence

Device product

Screwdriver Blade, Handle, Drill Bit, Part #313.945 Low Profile Neuro Screwdriver Blade/MR Safe/MQC/32mm Short Lot # 5053859 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.

Z-2189-2016

May 31, 2016

Class II

Product summary

Firm
Synthes (USA) Products LLC
Event
Event 74416
Status
Terminated
Classification
Class II
Quantity
50 units
Official record key
device-enforcement:Z-2189-2016

Official wording

Reason: 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.

Code information: Part Number: 313.945, Low Profile Neuro Screwdriver Blade/MR Safe/MQC/32mm Short, Lot # 5053859, mfg. 7/28/2005, No Expiration Date product provided Non Sterile

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.