Devices

Device Recall Drill Bits for Cervical Plate System

Model / Serial
Lot Numbers: 89427-2 R & 89427-3-R
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Nationwide Distribution including TX, IN, UT, AZ, GA, CA, AL, MI, and MN.
Product Description
Accessories for the Captiva Spine SmartLOX Cervical Plate System. Products are labeled in part: || "***Part Number CP40012***12mm Drill Bit***Lot Number 89427-2 R***" || "***Part Number CP40014***14mm Drill Bit***Lot Number 89427-3-R***" || The Captiva Spine SmartLOX Cervical Plate System is intended for the anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion.
Manufacturer
Captiva Spine, Inc
1 Event
- Recall of Device Recall Drill Bits for Cervical Plate System

Manufacturer

Captiva Spine, Inc

Manufacturer Address
Captiva Spine, Inc, 967 Alternate A1A, Suite1, Jupiter FL 33477
Manufacturer Parent Company (2017)
Captiva Spine Inc.
Source
USFDA

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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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