Devices

Device Recall Anspach 1.85 mm x 16 mm Fluted Router for MRI

Model / Serial
Part Number: SP-3013-00; SP-3013-01; SP-3013-02; SP-3013-03. Serial Numbers: 200042, 200044, 200014, 200056, 200064, 200055, 200044, 200038, 200013, 310009, 310007, 20043, 200145, 200144.
Product Classification
Neurological Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .
Product Description
ANSPACH***1.85mm x 16 mm Fluted Router for MRI***Rx Only*** || This device is intended to be used with Anspach Systems
Manufacturer
The Anspach Effort, Inc.
1 Event
- Recall of Device Recall Anspach 1.85 mm x 16 mm Fluted Router for MRI

Manufacturer

The Anspach Effort, Inc.

Manufacturer Address
The Anspach Effort, Inc., 4500 Riverside Drive, Palm Beach Gardens FL 33410-4235
Manufacturer Parent Company (2017)
Johnson & Johnson
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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