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Recall Observatory FDA recall evidence

Device product

Medicrea International Universal Counter Torque for use with the Pass TULIP [Spinal] System Ref : A22020500

Z-1234-2020

November 11, 2019

Class II

Product summary

Firm
Medicrea International
Event
Event 84765
Status
Terminated
Classification
Class II
Quantity
3 units
Official record key
device-enforcement:Z-1234-2020

Official wording

Reason: Incompatible universal counter torque (A22020500) with the nut driver T30 (A22020220)

Code information: Lot Number:19H0108 Exp.Date: 19/08/2029

Distribution pattern: CA, FL

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Incompatible universal counter torque (A22020500) with the nut driver T30 (A22020220)