Medagent Inc recalls Rebstock Holding rod for fixation -For holding and fixation of flexible Leyla Arms and spatula Art. No. 06-06-285 and 0…

Recall date

December 21, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1184-2024

FDA classification

Class II

Brand / firm

Medagent Inc

Sold / distributed

TX Foreign: Algeria China Dominican Republic Germany India Japan Philippines UK

Why it was recalled

Holding arm could move (twist) uncontrollably in the front area. This could lead to a serious deterioration of patient's safety if the movement is transferred to the spatula, which is attached to the holding arm.

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

What was recalled

Rebstock Holding rod for fixation -For holding and fixation of flexible Leyla Arms and spatula Art. No. 06-06-285 and 06-06-285MOD. surgical instrument.