Devices

Device Recall 1MM Fluted Ball, 7.3CM

Model / Serial
All lots are included in recall
Product Classification
Neurological Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution: US (nationwide) and Internationally to: AU, BE, CA, CH, ES, FR, GB, IT, JP, NL, SE, and ZA.
Product Description
MCA7-1SB - 1MM Fluted Ball, 7.3CM. All lots are included in recall. || Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
Manufacturer
The Anspach Effort, Inc.
1 Event
- Recall of Device Recall 1MM Fluted Ball, 7.3CM

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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