CLASS II ONGOING Device recall · Reported 6 Mar 2024 · FDA Enforcement Report
Rebstock Holding rod for fixation -For holding recalled by Medagent
Medagent is recalling Rebstock Holding rod for fixation -For holding and fixation of flexible Leyla Arms and, distributed in Texas. The recall was initiated on 21 Dec 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1184-2024
- FDA event ID
- 93840
- Recalling firm
- Medagent, Portsmouth, NH
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 21 Dec 2023
- FDA classified
- 23 Feb 2024
- Reported
- 6 Mar 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 21 Dec 2023 | Recall initiated by company | |
| 23 Feb 2024 | Classified by FDA | +64 days |
| 6 Mar 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
TX Foreign: Algeria China Dominican Republic Germany India Japan Philippines UK
Questions about this recall
Why was it 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.
Which lots are affected?
Batches: 6221672, 6222079, 6230282, 6230985, 6230986, 6231808, 6222559, 6231989, 6221673
Where was it sold?
TX Foreign: Algeria China Dominican Republic Germany India Japan Philippines UK
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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