Device Recall STRYKER NAVIGATION SYSTEM OrthoMap 3D

Verision 1.0; all batches: K1700F3001; K1800F3001; K1P00F3002; K3C00F3003; K4G00F3004; K9B00F3004; and L5L00F3004.

Neurological Devices

2

No

Worldwide Distribution -- USA, Canada, Mexico, Australia, Argentina, Brazil, United Kingdom, Japan, Poland, S. Korea, Hong Kong, Taiwan, India, and New Zealand.

Stryker Navigation System - OrthoMap 3D - Enable, Part number 6002-650-300. 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.

Verision 1.0; all batches: K1P00F3002; K2300F3002; and L2900F3004.

Neurological Devices

2

No

Worldwide Distribution -- USA, Canada, Mexico, Australia, Argentina, Brazil, United Kingdom, Japan, Poland, S. Korea, Hong Kong, Taiwan, India, and New Zealand.

Stryker Navigation System - OrthoMap 3D - Enable, Part number 6005-650-300. 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.

Verision 1.0; all batches: K8700F3004; KB300F3004; KC400F3004; L2500F3004; L4700F3004; and L4S00F3004.

Neurological Devices

2

No

Worldwide Distribution -- USA, Canada, Mexico, Australia, Argentina, Brazil, United Kingdom, Japan, Poland, S. Korea, Hong Kong, Taiwan, India, and New Zealand.

Stryker Navigation System - OrthoMap 3D - Planning, Part number 6005-651-000. 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.

All batches: K3X00F3016; K4700F3016; K5500F3016; K7X00F3016; K8S00F3016; K9100F3016; KBC00F3016; and L1V00F3016.

Neurological Devices

2

No

Worldwide Distribution -- USA, Canada, Mexico, Australia, Argentina, Brazil, United Kingdom, Japan, Poland, S. Korea, Hong Kong, Taiwan, India, and New Zealand.

Stryker Navigation System - OrthoMap 3D (Sales Demos), Part number 81-81016. 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.