FDA-Device2024-03-06Class II

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.

Medagent Inc
Hazard

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.

Sold states
TX Foreign: Algeria China Dominican Republic Germany India Japan Philippines UK
Affected count
84 units
Manufactured in
264 Lafayette Rd Ste 7, Portsmouth, NH, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1184-2024

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