Devices

Device Recall NOVATION MODULAR DRILL BIT

Model / Serial
Catalog Number: 101-05-40. Serial Numbers:2193123 and 2193124.
Product Classification
Orthopedic Devices
Device Class
1
Implanted device?
No
Distribution
Nationwide distribution: USA state of: Arkansas only
Product Description
REF 101-05-40***NOVATION MODULAR DRILL BIT LENGTH: 40mm, DIAMETER 3.2mm***Use with 40mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Gainesville, FL 32653***. || To assist the surgeon in the implantation of Novation Hip system components in according to a conventional technique for hemi & total hip arthroplasty. Specifically, these instruments are reusable, surgically invasive, and intended for transient use.
Manufacturer
Exactech, Inc.
1 Event
- Recall of Device Recall NOVATION MODULAR DRILL BIT

Manufacturer

Exactech, Inc.

Manufacturer Address
Exactech, Inc., 2320 NW 66th Ct, Gainesville FL 32653-1630
Manufacturer Parent Company (2017)
Exactech Inc
Source
USFDA

5 devices with a similar name

Learn more about the data here

Device Recall NOVATION MODULAR DRILL BIT

Model / Serial
Catalog Number 101-05-20; Serial Numbers: 2179820 and 2216759.
Product Classification
Orthopedic Devices
Device Class
1
Implanted device?
No
Distribution
Nationwide distribution: USA state of: Arkansas only
Product Description
REF 101-05-20***NOVATION MODULAR DRILL BIT LENGTH: 20mm, DIAMETER 3.2mm***Use with 20mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Gainesville, FL 32653***. || To assist the surgeon in the implantation of Novation Hip system components in according to a conventional technique for hemi & total hip arthroplasty. Specifically, these instruments are reusable, surgically invasive, and intended for transient use.
Manufacturer
Exactech, Inc.

Device Recall NOVATION MODULAR DRILL BIT

Model / Serial
Catalog Number: 101-05-30. Serial Numbers:2218601 and 2218603.
Product Classification
Orthopedic Devices
Device Class
1
Implanted device?
No
Distribution
Nationwide distribution: USA state of: Arkansas only
Product Description
REF 101-05-30***NOVATION MODULAR DRILL BIT LENGTH: 30mm, DIAMETER 3.2mm***Use with 30mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Gainesville, FL 32653***. || To assist the surgeon in the implantation of Novation Hip system components in according to a conventional technique for hemi & total hip arthroplasty. Specifically, these instruments are reusable, surgically invasive, and intended for transient use.
Manufacturer
Exactech, Inc.

Device Recall NOVATION MODULAR DRILL BIT

Model / Serial
Catalog Number: 101-45-20. Serial Numbers:2138948 and 2138950.
Product Classification
Orthopedic Devices
Device Class
1
Implanted device?
No
Distribution
Nationwide distribution: USA state of: Arkansas only
Product Description
REF 101-45-20***NOVATION MODULAR DRILL BIT LENGTH: 20mm, DIAMETER 4.5mm***Use with 20mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Gainesville, FL 32653***. || To assist the surgeon in the implantation of Novation Hip system components in according to a conventional technique for hemi & total hip arthroplasty. Specifically, these instruments are reusable, surgically invasive, and intended for transient use.
Manufacturer
Exactech, Inc.

Device Recall NOVATION MODULAR DRILL BIT

Model / Serial
Catalog Number: 101-45-30. Serial Numbers:2139027 and 2139028.
Product Classification
Orthopedic Devices
Device Class
1
Implanted device?
No
Distribution
Nationwide distribution: USA state of: Arkansas only
Product Description
REF 101-45-30***NOVATION MODULAR DRILL BIT LENGTH: 30mm, DIAMETER 4.5mm***Use with 30mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Gainesville, FL 32653***. || To assist the surgeon in the implantation of Novation Hip system components in according to a conventional technique for hemi & total hip arthroplasty. Specifically, these instruments are reusable, surgically invasive, and intended for transient use.
Manufacturer
Exactech, Inc.

Device Recall NOVATION MODULAR DRILL BIT

Model / Serial
Catalog Number: 101-45-20. Serial Numbers:2139099 and 2139100.
Product Classification
Orthopedic Devices
Device Class
1
Implanted device?
No
Distribution
Nationwide distribution: USA state of: Arkansas only
Product Description
REF 101-45-40***NOVATION MODULAR DRILL BIT LENGTH: 40mm, DIAMETER 4.5mm***Use with 40mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Gainesville, FL 32653***. || To assist the surgeon in the implantation of Novation Hip system components in according to a conventional technique for hemi & total hip arthroplasty. Specifically, these instruments are reusable, surgically invasive, and intended for transient use.
Manufacturer
Exactech, 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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