Devices

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.
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

Learn more about the data here

Anspach Single Use, Sterile Bone Cutting Burrs

Model / Serial
MCA5-2SD: D163033602, C523029656, and D093032545. MCA7-2SD: D063031861, D243033598, and D133033340.
Product Classification
Neurological Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution-USA (nationwide) and the countries of Australia, Belgium, France, Italy, Japan, South Africa, Spain, Sweden, and United Kingdom.
Product Description
"***REF MCA5-15SB QTY: 1***1.5 mm Fluted Ball, 5.6 cm. Use with Micro Curved Attachment (MCA).***Sterilized using Irradiation***RX Only***ANSPACH Manufacture 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, Hp 11 1LA United Kingdom Tel: +441494 616126***" || "***REF MCA7-15SB QTY: 1***1.5 mm Fluted Ball, 7.3 cm. Use with Micro Curved Attachment (MCA).***Sterilized using Irradiation***RX Only***ANSPACH Manufacture 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, Hp 11 1LA United Kingdom Tel: +441494 616126***" || Cutting and Shaping bone including bones of the spine and cranium
Manufacturer
The Anspach Effort, Inc.

Anspach Single Use, Sterile Bone Cutting Burrs

Model / Serial
MCA5-15SD: D193034893, C523029661, and D093032547. MCA7-15SD: D233033710, C523029653, and D093032544.
Product Classification
Neurological Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution-USA (nationwide) and the countries of Australia, Belgium, France, Italy, Japan, South Africa, Spain, Sweden, and United Kingdom.
Product Description
***REF MCA5-15SD, QTY: 1***1.5 mm Diamond Ball, 5.6 cm. Use with Micro Curved Attachment (MCA).***Sterilized using Irradiation***RX Only***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***Anspach Europe Ltd. Aston Court, Kingsmead Business Park Frederick Place High Wycombe, HP 11 1LA United Kingdom Tel: +441494 616126*** || ***REF MCA7-15SD, QTY: 1***1.5 mm Diamond Ball, 7.3 cm. Use with Micro Curved Attachment (MCA).***Sterilized using Irradiation***RX Only***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***Anspach Europe Ltd. Aston Court, Kingsmead Business Park Frederick Place High Wycombe, HP 11 1LA United Kingdom Tel: +441494 616126*** || Cutting and Shaping bone including bones of the spine and cranium
Manufacturer
The Anspach Effort, Inc.

Anspach Single Use, Sterile Bone Cutting Burrs

Model / Serial
MCA5-15SB: D093032542, D063031862, C523029660, D173033269, and D223034370. MCA7-15SB: D223034655, D063031866, C523029663, and D093032540.
Product Classification
Neurological Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution-USA (nationwide) and the countries of Australia, Belgium, France, Italy, Japan, South Africa, Spain, Sweden, and United Kingdom.
Product Description
***REF MCA5-1SB, QTY: 1***1 mm Fluted Ball, 5.6 cm. Use with Micro Curved Attachment (MCA).***Sterilized using Irradiation***RX Only***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***Anspach Europe Ltd. Aston Court, Kingsmead Business Park Frederick Place High Wycombe, HP 11 1LA United Kingdom Tel: +441494 616126*** || ***REF MCA7-1SB, QTY: 1***1 mm Fluted Ball, 7.3 cm. Use with Micro Curved Attachment (MCA).***Sterilized using Irradiation***RX Only***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***Anspach Europe Ltd. Aston Court, Kingsmead Business Park Frederick Place High Wycombe, HP 11 1LA United Kingdom Tel: +441494 616126*** || Cutting and Shaping bone including bones of the spine and cranium
Manufacturer
The Anspach Effort, Inc.

Anspach Single Use, Sterile Bone Cutting Burrs

Model / Serial
MCA5-2SB: D163033908, D253036524, and D063031864. MCA7-2SB: D243033308.
Product Classification
Neurological Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution-USA (nationwide) and the countries of Australia, Belgium, France, Italy, Japan, South Africa, Spain, Sweden, and United Kingdom.
Product Description
***REF MCA5-2SB, QTY: 1***2 mm Fluted Ball, 5.6 cm. Use with Micro Curved Attachment (MCA).***Sterilized using Irradiation***RX Only***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***Anspach Europe Ltd. Aston Court, Kingsmead Business Park Frederick Place High Wycombe, HP 11 1LA United Kingdom Tel: +441494 616126*** || ***REF MCA7-2SB, QTY: 1***2 mm Fluted Ball, 7.3 cm. Use with Micro Curved Attachment (MCA).***Sterilized using Irradiation***RX Only***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***Anspach Europe Ltd. Aston Court, Kingsmead Business Park Frederick Place High Wycombe, HP 11 1LA United Kingdom Tel: +441494 616126*** || Cutting and Shaping bone including bones of the spine and cranium
Manufacturer
The Anspach Effort, Inc.

Anspach Single Use, Sterile Bone Cutting Burrs

Model / Serial
MCA5-1SD: C523029669, D173033306, D113032936, and D313037658. MCA7-1SD: D253036521, C523029670, and D293037517.
Product Classification
Neurological Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution-USA (nationwide) and the countries of Australia, Belgium, France, Italy, Japan, South Africa, Spain, Sweden, and United Kingdom.
Product Description
***REF MCA5-1SD, QTY: 1***1 mm Diamond Ball, 5.6 cm. Use with Micro Curved Attachment (MCA).***Sterilized using Irradiation***RX Only***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***Anspach Europe Ltd. Aston Court, Kingsmead Business Park Frederick Place High Wycombe, HP 11 1LA United Kingdom Tel: +441494 616126*** || ***REF MCA7-1SD, QTY: 1***1 mm Diamond Ball, 7.3 cm. Use with Micro Curved Attachment (MCA).***Sterilized using Irradiation***RX Only***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***Anspach Europe Ltd. Aston Court, Kingsmead Business Park Frederick Place High Wycombe, HP 11 1LA United Kingdom Tel: +441494 616126*** || Cutting and Shaping bone including bones of the spine and cranium
Manufacturer
The Anspach Effort, Inc.

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