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.
Reported: March 6, 2024 Initiated: December 21, 2023 #Z-1184-2024
Product Description
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.
Details
- Recalling Firm
- Medagent Inc
- Units Affected
- 84 units
- Distribution
- TX Foreign: Algeria China Dominican Republic Germany India Japan Philippines UK
- Location
- Portsmouth, NH
Frequently Asked Questions
What product 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.. Recalled by Medagent Inc. Units affected: 84 units.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on March 6, 2024. Severity: Moderate. Recall number: Z-1184-2024.
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