Surgical driver systems recalled over out of the box driver wobble
IPC Powerease System units, REF 2300000, are recalled because of out of the box wobble of the driver. 214 units are affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Rubric level 2 covers precautionary recalls; the notice states only that the driver wobbles out of the box, without describing any patient consequence.
Plain-English summary
The IPC Powerease System, REF 2300000, UDI-DI 00613994448705 and 00643169406834, is being recalled. The system is indicated for drilling, tapping and driving screws and working end attachments during spinal surgery, including open and minimally invasive procedures. Affected serial numbers include PEU21207, PEU21208 and PEU21210, with the full list in the recall notice. The recall covers 214 units distributed across more than 25 states and internationally.
The recall was issued because of out of the box wobble of the driver. The FDA classified the action as Class II. The notice does not describe a further consequence.
Hospitals and surgical centres holding these serial numbers should quarantine affected units and follow the manufacturer's instructions for return or replacement.
The recalled product
- Product
- IPC Powerease System REF 2300000 UDI-DI: 00613994448705 00643169406834. The IPC POWEREASE System is indicated for drilling, tapping, and driving screws and working end attachments during spinal surgery, including open and minimally invasive procedures. The IPC POWEREASE…
- Manufacturer
- Medtronic Xomed, Inc.
- Affected units
- 214
Distribution
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