Devices

Device Recall TransFx External Fixation System Drill Bit

Model / Serial
Lots 56454675, 70185900, 70238100,70247500 and 70249700.
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Worldwide Distribution -- USA, Australia, Canada, El Salvador, England, Germany, Latin America, and Singapore.
Product Description
TransFx External Fixation System Drill Bit, Quick Connect, 3.5 mm diameter, 195 mm length, nonsterile, Zimmer, Warsaw, IN; REF 4450-61. TransFx drill bits can be found in the following kits: TransFx Intermediate External Fixation System, REF 4450-05-10; TransFx Large External Fixation System, REF 4450-010-10 and TransFx Small External Fixation System, REF 4450-00050-15. || For use in pre-drilling bone to accept a fixation pin, which are part of the external fixation structure that the surgeon assembles intra-operatively to stabilize bone fractures from the extremities.
Manufacturer
Zimmer Inc.
1 Event
- Recall of Device Recall TransFx External Fixation System Drill Bit

Manufacturer

Zimmer Inc.

Manufacturer Address
Zimmer Inc., 345 E Main St, Warsaw IN 46580-2746
Source
USFDA

6 devices with a similar name

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Device Recall TransFx External Fixation System Drill Bit

Model / Serial
Lots 52987100, 53024600, 56454682, 56454683, 5645684, 70185500, 70196100, 70203500, 70211400, 70216000, 70244300 and 70244400.
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Worldwide Distribution -- USA, Australia, Canada, El Salvador, England, Germany, Latin America, and Singapore.
Product Description
TransFx External Fixation System Drill Bit, Quick Connect, 2.0 mm diameter, 125 mm length, nonsterile, Zimmer, Warsaw, IN; REF 4450-54. TransFx drill bits can be found in the following kits: TransFx Intermediate External Fixation System, REF 4450-05-10; TransFx Large External Fixation System, REF 4450-010-10 and TransFx Small External Fixation System, REF 4450-00050-15. || For use in pre-drilling bone to accept a fixation pin, which are part of the external fixation structure that the surgeon assembles intra-operatively to stabilize bone fractures from the extremities.
Manufacturer
Zimmer Inc.

Device Recall TransFx External Fixation System Drill Bit

Model / Serial
Lots 53024700, 56454687, 5645689, 56454690, 56454691, 70185600, 70202700, 70216100, 70227200, 70244500, 70244600, 70244700 and 70244800.
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Worldwide Distribution -- USA, Australia, Canada, El Salvador, England, Germany, Latin America, and Singapore.
Product Description
TransFx External Fixation System Drill Bit, Quick Connect, 2.5 mm diameter, 180 mm length, nonsterile, Zimmer, Warsaw, IN; REF 4450-56. TransFx drill bits can be found in the following kits: TransFx Intermediate External Fixation System, REF 4450-05-10; TransFx Large External Fixation System, REF 4450-010-10 and TransFx Small External Fixation System, REF 4450-00050-15. || For use in pre-drilling bone to accept a fixation pin, which are part of the external fixation structure that the surgeon assembles intra-operatively to stabilize bone fractures from the extremities.
Manufacturer
Zimmer Inc.

Device Recall TransFx External Fixation System Drill Bit

Model / Serial
Lots 53007600, 53024800, 56454669, 70185700, 70221300, 70227300, 70249300, 70249400, 70250100 and 70254900.
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Worldwide Distribution -- USA, Australia, Canada, El Salvador, England, Germany, Latin America, and Singapore.
Product Description
TransFx External Fixation System Drill Bit, Quick Connect, 3.0 mm diameter, 180 mm length, nonsterile, Zimmer, Warsaw, IN; REF 4450-58. TransFx drill bits can be found in the following kits: TransFx Intermediate External Fixation System, REF 4450-05-10; TransFx Large External Fixation System, REF 4450-010-10 and TransFx Small External Fixation System, REF 4450-00050-15. || For use in pre-drilling bone to accept a fixation pin, which are part of the external fixation structure that the surgeon assembles intra-operatively to stabilize bone fractures from the extremities.
Manufacturer
Zimmer Inc.

Device Recall TransFx External Fixation System Drill Bit

Model / Serial
Lots 53007700, 53022100, 53022200, 56454692, 56454693, 56454694, 56454695, 56454696, 56454697, 56454698, 70186000, 70193000, 70205400, 70247600, 70247700 and 70254400.
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Worldwide Distribution -- USA, Australia, Canada, El Salvador, England, Germany, Latin America, and Singapore.
Product Description
TransFx External Fixation System Drill Bit, Quick Connect, 4.0 mm diameter, 195 mm length, nonsterile, Zimmer, Warsaw, IN; REF 4450-63. TransFx drill bits can be found in the following kits: TransFx Intermediate External Fixation System, REF 4450-05-10; TransFx Large External Fixation System, REF 4450-010-10 and TransFx Small External Fixation System, REF 4450-00050-15. || For use in pre-drilling bone to accept a fixation pin, which are part of the external fixation structure that the surgeon assembles intra-operatively to stabilize bone fractures from the extremities.
Manufacturer
Zimmer Inc.

Device Recall TransFx External Fixation System Drill Bit

Model / Serial
Lots 56454678 and 70186200.
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Worldwide Distribution -- USA, Australia, Canada, El Salvador, England, Germany, Latin America, and Singapore.
Product Description
TransFx External Fixation System Drill Bit, Quick Connect, 4.5 mm diameter, 230 mm length, nonsterile, Zimmer, Warsaw, IN; REF 4450-65. TransFx drill bits can be found in the following kits: TransFx Intermediate External Fixation System, REF 4450-05-10; TransFx Large External Fixation System, REF 4450-010-10 and TransFx Small External Fixation System, REF 4450-00050-15. || For use in pre-drilling bone to accept a fixation pin, which are part of the external fixation structure that the surgeon assembles intra-operatively to stabilize bone fractures from the extremities.
Manufacturer
Zimmer 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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