Stryker Instruments, Instruments Div.

All systems with a rover top cap assembly 711-27-001 manufactured from 1/1/01 to 12/31/01. The recalled caps can be visually distinguished because there is a flat lip where the lid connects to the unit, and the flat lip is covered by a metal retaining ring which holds the cap in place. Non-recalled units do not have a metal retaining ring, rather the caps are held in place by screws with ribs in the cap on either side of each screw.

General Hospital and Personal Use Devices

2

No

United States

Stryker brand Neptune waste management system; model 711-27-1.

lot 03030232.

Orthopedic Devices

United States, Canada, Italy, Japan and United Kingdom

Stryker Advanced Cement Mixing System Bowl and 180 Gram Cement Cartridge with Break-Away Femoral Nozzle for use with Stryker high vacuum cement injection system, 6 pack; part 0306-563-000.

Lots 03082022, 03082042, 0308102, 03082122, 03082162, 03082202, 03082222, 03092242, 03092302, 03092322, 03092342, 03092402, 03092422, 03092442 and 03092462.

General Hospital and Personal Use Devices

2

No

United States, France and United Kingdom.

Stryker brand OrthoTec pulsed irrigation/suction handpiece and tubing set; part number 0203-020-000.

Serial numbers PG04-0001 through PG04-0017.

Neurological Devices

2

No

United States.

Stryker Navigation System - Hip Module Patient Tracker, green; Model 6007-005-000.

Serial numbers PG04-0006 through PG04-0017.

Neurological Devices

2

No

United States.

Stryker Navigation System - Hip Module Patient Tracker, blue; Model 6007-010-000.