Devices

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.
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

Device Recall AnspacSingle use Sterile bone cutting burs

Model / Serial
Lot #'s: D293037349, D323038110 and D363039140
Product Classification
Neurological Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - USA including CA, CO, IN, KY, MD and TX and Internationally to Japan, Taiwan, United Kingdom, Sweden, and Germany.
Product Description
AnspacSingle use Sterile bone cutting burs.h REF: S-1504TD Twist Drill for 1.5mm x 4mm screw. Rx only || Single use Sterile bone cutting burs.
Manufacturer
The Anspach Effort, Inc.

Anspach Single Use Sterile Bone Cutting Burrs

Model / Serial
Manufacturer
The Anspach Effort Inc

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.

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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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