Medical device recalls Moderate risk

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

Recall date
November 11, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1234-2020
FDA classification
Class II
Brand / firm
Medicrea International
Sold / distributed
CA, FL

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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