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Recall Observatory FDA recall evidence

Device product

Synthes VA Implant Rack for the Compact Distal Radius System Tray/Surgical/Instrument

Z-0867-2017

November 29, 2016

Class II

Product summary

Firm
Synthes (USA) Products LLC
Event
Event 75828
Status
Terminated
Classification
Class II
Quantity
31 units
Official record key
device-enforcement:Z-0867-2017

Official wording

Reason: The screw rack plate was assembled incorrectly which could cause the screws in the screw rack to sit low and touch the surface beneath the screw rack.

Code information: Catalog ID (part # 60.119.012), Lot Number FL00528

Distribution pattern: Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The screw rack plate was assembled incorrectly which could cause the screws in the screw rack to sit low and touch the surface beneath the screw rack.