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Devices
G1 cutting tools
Model / Serial
REF M-5B-27-G1 ; ALL lot numbers.
Product Classification
Neurological Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - US including AZ, CA, CO, FL, GA, IL, KY, LA, MN, MO, NC, NJ, NY, OH, OR, PA, TX, and Internationally to Canada and China.
Product Description
ANSPACH - 5MM Fluted Ball, Extends 27MM; || REF M-5B-27-G1. || Cutting shaping bone including spine and cranium.
Manufacturer
The Anspach Effort, Inc.
1 Event
Recall of G1 cutting tools
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Manufacturer
The Anspach Effort, Inc.
Manufacturer Address
The Anspach Effort, Inc., 4500 Riverside Dr, Palm Beach Gardens FL 33410-4235
Manufacturer Parent Company (2017)
Johnson & Johnson
Source
USFDA
10 devices with a similar name
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Anspach G1 cutting tools
Model / Serial
REF S-4DC-22-G1 ; ALLlot numbers.
Product Classification
Neurological Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - US including AZ, CA, CO, FL, GA, IL, KY, LA, MN, MO, NC, NJ, NY, OH, OR, PA, TX, and Internationally to Canada and China.
Product Description
ANSPACH -4MM Coarse Diamond Ball, 22MM Shaft Exposure; REF S-4DC-22-G1 || Cutting shaping bone including spine and cranium.
Manufacturer
The Anspach Effort, Inc.
Anspach G1 cutting tools
Model / Serial
REF S-4D-L-G1 ; ALL lot numbers.
Product Classification
Neurological Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - US including AZ, CA, CO, FL, GA, IL, KY, LA, MN, MO, NC, NJ, NY, OH, OR, PA, TX, and Internationally to Canada and China.
Product Description
ANSPACH - 4MM Diamond Ball, Extends 27MM; REF S-4D-L-G1 all lot numbers || Cutting shaping bone including spine and cranium.
Manufacturer
The Anspach Effort, Inc.
Anspach G1 cutting tools
Model / Serial
REF S-5B-2-G1 ; ALL lot numbers.
Product Classification
Neurological Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - US including AZ, CA, CO, FL, GA, IL, KY, LA, MN, MO, NC, NJ, NY, OH, OR, PA, TX, and Internationally to Canada and China.
Product Description
ANSPACH - 5MM Fluted Ball, 2MM Shaft Exposure; REF S-5B-2-G1 || Cutting shaping bone including spine and cranium.
Manufacturer
The Anspach Effort, Inc.
Anspach G1 cutting tools
Model / Serial
REF S-5D-2-G1 ; ALL lot numbers.
Product Classification
Neurological Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - US including AZ, CA, CO, FL, GA, IL, KY, LA, MN, MO, NC, NJ, NY, OH, OR, PA, TX, and Internationally to Canada and China.
Product Description
ANSPACH - 5MM Diamond Ball, 2MM Shaft Exposure; || REF S-5D-2-G1 || Cutting shaping bone including spine and cranium.
Manufacturer
The Anspach Effort, Inc.
Anspach G1 cutting tools
Model / Serial
REF M-4B-27-G1 ; ALL lot numbers.
Product Classification
Neurological Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - US including AZ, CA, CO, FL, GA, IL, KY, LA, MN, MO, NC, NJ, NY, OH, OR, PA, TX, and Internationally to Canada and China.
Product Description
ANSPACH - 4MM Fluted Ball, Extends 27MM; || REF M-4B-27-G1. || Cutting shaping bone including spine and cranium.
Manufacturer
The Anspach Effort, Inc.
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