FDA recall Z-1184-2024

Medagent Inc · Class II · device

Product

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.

Reason for recall

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.

Distribution

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

Key facts

Status
Ongoing
Initiation date
2023-12-21
Report date
2024-03-06
Voluntary/Mandated
Voluntary: Firm initiated
Location
Portsmouth, NH, United States

Primary source

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