Reported Mar 6, 2024 · Ongoing
Rebstock Holding rod for fixation -For holding and fixation of flexible Leyla Arms and spatula Art. No. 06-06-285 and…
Medagent Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medagent Inc · 264 Lafayette Rd Ste 7 · Portsmouth, NH · 03801-5430
Is this the product you have?
- 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.
- Lot codes and dates
- Batches
622167262220796230282623098562309866231808622255962319896221673
- Batches
- Amount recalled
- 84 units
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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