Devices

Sterile Bone Cutting Bur

Model / Serial
Lot numbers: D063031866, C523029663, D093032540, D113032924, D113032979, D123033073, and D223034655.
Product Classification
Orthopedic Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide distribution: USA including states of: AZ, CA, FL, GA, IL, IN, LA, MA, and MI; and countries of: Australia, Belgium, England, France, Italy, Japan, South Africa, Spain and Sweden.
Product Description
***REF MCA7-15SB*** 1.5 mm Fluted Ball, 7.3 cm. Use with Micro Curved Attachment.***ANSPACH***Sterile, Sterilized using Irradiation***Rx Only*** Made in the USA***Manufacturer: The Anspach Effort, Inc. 4500 Riverside Drive, Palm Beach Gardens, FL 33410 USA Tel: (800) 327 6887/ +1 561 627 1080***Anspach Europe Ltd. Aston Court, Kingsmead Business Park Frederick Place High Wycombe, HP11 1LA United Kingdom Tel: +441494 616126*** || Lot numbers: D063031866, C523029663, D093032540, D113032924, D113032979, D123033073, and D223034655. || Intended usage: Cutting and shaping bone including bones of the spine and cranium.
Manufacturer
The Anspach Effort, Inc.
1 Event
- Recall of Sterile Bone Cutting Bur

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

38 devices with a similar name

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Sterile Bone Cutting Bur

Model / Serial
Lot numbers: C523029660, D063031862, D093032542, D113032933, D113032970, D173033269, and D223034370.
Product Classification
Orthopedic Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide distribution: USA including states of: AZ, CA, FL, GA, IL, IN, LA, MA, and MI; and countries of: Australia, Belgium, England, France, Italy, Japan, South Africa, Spain and Sweden.
Product Description
***REF MCA5-15SB ***1.5 mm Fluted Ball, 5.6 cm. Use with Micro Curved Attachment (MCA).***ANSPACH***Sterile, Sterilized using Irradiation***Rx Only*** Made in the USA***Manufacturer: The Anspach Effort, Inc. 4500 Riverside Drive, Palm Beach Gardens, FL 33410 USA Tel: (800) 327-6887/ +1 561 627 1080***Anspach Europe Ltd. Aston Court, Kingsmead Business Park Frederick Place High Wycombe, HP11 1LA United Kingdom Tel: +441494 616126*** || Lot numbers: C523029660, D063031862, D093032542, D113032933, D113032970, D173033269, and D223034370. || Intended usage: Cutting and shaping bone including bones of the spine and cranium.
Manufacturer
The Anspach Effort, Inc.

Sterile Bone Cutting Bur

Model / Serial
Lot numbers: C523029666, D063031864, D113032937, D113032974, D163033908, D253036524, and D353039102.
Product Classification
Orthopedic Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide distribution: USA including states of: AZ, CA, FL, GA, IL, IN, LA, MA, and MI; and countries of: Australia, Belgium, England, France, Italy, Japan, South Africa, Spain and Sweden.
Product Description
***REF MCA5-2SB*** 2 mm Fluted Ball, 5.6 cm. Use with Micro Curved Attachment (MCA).***ANSPACH***Sterile, Sterilized using Irradiation***Rx Only*** Made in the USA***Manufacturer: The Anspach Effort, Inc. 4500 Riverside Drive, Palm Beach Gardens, FL 33410 USA Tele: (800) 327-6887/ + 1 561 627 1080***Anspach Europe Ltd. Aston Court, Kingsmead Business Park Frederick Place High Wycombe, HP11 1LA United Kingdom Tel: +441494 616126*** || Lot numbers: C523029666, D063031864, D113032937, D113032974, D163033908, D253036524, and D353039102. || Intended usage: Cutting and shaping bone including bones of the spine and cranium.
Manufacturer
The Anspach Effort, Inc.

Sterile Bone Cutting Bur

Model / Serial
Lot numbers: C523029652, D063031867, D113032925, D173034373 and D213035424.
Product Classification
Orthopedic Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide distribution: USA including states of: AZ, CA, FL, GA, IL, IN, LA, MA, and MI; and countries of: Australia, Belgium, England, France, Italy, Japan, South Africa, Spain and Sweden.
Product Description
***REF MCA7-1SB*** 1 mm Fluted Ball, 7.3 cm. Use with Micro Curved Attachment (MCA).***ANSPACH***Sterile, Sterilized using Irradiation***Rx Only***Made in the USA***Manufacturer: The Anspach Effort, Inc. 4500 Riverside Drive, Palm Beach Gardens, FL 33410 USA Tel: (800) 327 6887/ +1 561 627 1080***Anspach Europe Ltd. Aston Court, Kingsmead Business Park Frederick Place High Wycombe, HP11 1LA United Kingdom Tel: +441494 616126*** || Lot numbers: C523029652, D063031867, D113032925, D173034373 and D213035424. || Intended usage: Cutting and shaping bone including bones of the spine and cranium.
Manufacturer
The Anspach Effort, Inc.

Sterile Bone Cutting Bur

Model / Serial
Lot numbers: C523029789, D113032927, D333038386, D113032982, D093032541 and D243033308.
Product Classification
Orthopedic Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide distribution: USA including states of: AZ, CA, FL, GA, IL, IN, LA, MA, and MI; and countries of: Australia, Belgium, England, France, Italy, Japan, South Africa, Spain and Sweden.
Product Description
***REF MCA7-2SB***2 mm Fluted Ball, 7.3 cm. Use with Micro Curved Attachment (MCA).***ANSPACH***Sterile, Sterilized using Irradiation***Rx Only ***Made in the USA***Manufacturer: The Anspach Effort, Inc. 4500 Riverside Drive, Palm Beach Gardens, FL 33410 USA Tel: (800) 327-6887 / + 1 561 627 1080***Anspach Europe Ltd. Aston Court, Kingsmead Business Park Frederick Place High wycombe, HP11 1LA United Kingdom Tel: +441494 616126*** || Lot numbers: C523029789, D113032927, D333038386, D113032982, D093032541 and D243033308. || Intended usage: Cutting and shaping bone including bones of the spine and cranium.
Manufacturer
The Anspach Effort, Inc.

Device Recall Anspach Single Use, Sterile Bone Cutting Burrs model IMRIS8NSM

Model / Serial
Batch # - C323023789
Product Classification
Neurological Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution--USA (nationwide) including the states of Alabama, California, and Wisconsin and the countries of Columbia, France, Germany, Great Britain, Italy, Panama, Poland, Saudi Arabia, South Africa, Spain, and Switzerland.
Product Description
Sterile Bone Cutting Burrs model IMRI-S-8NS-M labeled in part:***IMRI-S-8NS-M***QTY: 1***3 mm Fluted Matchstick, Extends 8.9 mm,***Less Aggressive. Use with IMRI-SHORT***Attachments.***Use by 2014 08***ANSPACH***Manufacturer***Made in USA***The Anspach Effort, Inc.***4500 Riverside Drive***Palm Beach Gardens, FL 33410, USA***Tel: (800) 327 6887 / + 1 561 627 1080***EC REP***Anspach Europe Ltd.***Aston Court, Kingsmead Business Park***Frederick Place***High Wycombe, HP 11 1LA***United Kingdom***Tel: +441494 616126***Rx Only***LOT C323023789***. || Cutting and Shaping bone including bones of the spine and cranium.
Manufacturer
The Anspach Effort, Inc.

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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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