Devices

Device Recall STRYKER NAVIGATION SYSTEM SpineMap 3D Upgrade

Model / Serial
Verision 1.0; all batches: K1M00F3002; K1P00F3002; K1T00F3002; K2L00F3002; K2S00F3003; K3C00F3003; K3Q00F3003; K4U00F3004; K5700F3004; K5L00F3004; K7H00F3004; K8K00F3004; L5J00F3004; and L6E00F3004.
Product Classification
Neurological Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution -- USA, Canada, Mexico, Australia, Argentina, Brazil, United Kingdom, Japan, Poland, S. Korea, Hong Kong, Taiwan, India, and New Zealand.
Product Description
Stryker Navigation System - SpineMap 3D - Upgrade, Part number 6002-650-100. It provides precise stereostatic determination of surgical targets using stereostatic methodology. The three principle features include computer calculation of stereostatic coordinates from the diagnostic images, measurement of the stereostatic coordinates within the surgical field, high-resolution computer display or diagnostic images with stereostatic coordinates indicated. The system is comprised of software and hardware components.
Manufacturer
Stryker Instruments Division of Stryker Corporation
1 Event
- Recall of Device Recall STRYKER NAVIGATION SYSTEM SpineMap 3D Upgrade

Manufacturer

Stryker Instruments Division of Stryker Corporation

Manufacturer Address
Stryker Instruments Division of Stryker Corporation, 4100 East Milham Ave., Kalamazoo MI 49001
Manufacturer Parent Company (2017)
Stryker
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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