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Recall Observatory FDA recall evidence

Device product

Part #311.039, Handle with Mini QC Small, Lot # 4401497, 4687440, 4687441, 5639684, 4415131,4663839, 5623098 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-2193-2016

May 31, 2016

Class II

Product summary

Firm
Synthes (USA) Products LLC
Event
Event 74416
Status
Terminated
Classification
Class II
Quantity
29 units
Official record key
device-enforcement:Z-2193-2016

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 #311.039, Handle with Mini QC Small, Lot # 4401497, 4687440, 4687441, 5639684, 4415131,4663839, 5623098

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.