Device Recall Stryker

Lot Numbers Affected: 13604

Orthopedic Devices

1

No

GA, UT, MD, NJ, MT

Stryker FlowPort II Adapter: Model number: 00CAT00778 || The FlowPort II Adapter is intended to connect the FlowPort II Cannulas to commercially available, 4mm arthroscopes in surgical procedures.

Model Number(s): 0910-192-000 Lot Numbers Affected 61406007 expiration date: 8/31/2015

Cardiovascular Devices

2

No

Nationwide Distribution including PA and SC.

Cournand Modified 2-PC 19G, 5.4cm or (Guidewire Introducer Needle) || 20 units per case || The Stryker Guidewire Introducer Needles are designed for the percutaneous puncture of the anterior/posterior wall of a blood vessel. This provides an entry for a guidewire, vessel dilator, sheath, and catheter introduction.

model number: 2920-000-000 units serialized

General Hospital and Personal Use Devices

2

No

Worldwide Distribution - US Nationwide and the countries of Brazil, Canada, Chile, France, Hong Kong, Italy, Mexico, South Korea, Switzerland, United Kingdom.

Stryker Position Pro Mattress. || Mattress, Air Flotation, Alternating Pressure. || PositionPRO is a powered pressure relief support surface with low air loss (LAL) intended for medical purposes. PositionPRO consists of multiple air cells filled and emptied by an integrated control unit to provide changes in the distribution of body weight for pressure relief. PositionPRO offers turn assist. PositionPRO is for use with GoBed II¿, Secure II/3¿, InTouch¿, and Epic II¿ 84 in. x 35 in. flat deck frames. This surface is powered via an AC power cord that comes in either a 4 foot long option (PN QDF8087) or 15 foot long option (PN QDF8088). The 4 foot long option is used when the surface is plugged into the auxiliary outlet of the bed. The 15 foot long option is utilized when the surface needs to be plugged into a wall outlet. This product uses a power cord, manufactured by ElectriCord that plugs into the wall outlet or the auxiliary outlet of the bed that the surface is placed onto.

All lots of the following Catalog Numbers: 2704-1-024; 2704-3-018; 6703-1-018; 6703-2-120; 6704-1-018; 6704-2-120 and 6704-3-120.

Orthopedic Devices

2

Yes

Nationwide Distribution.

Stryker Vitallium Wire (6 Pack) Non Sterile. For use in bone procedures.

Lot #144933, 14D252, and 14D253.

Orthopedic Devices

1

No

Nationwide Distribution

Stryker Aero-AL Impaction handle Catalog Number 48921007. Stryker Spine Manufactured by : Stryker Spine SAS France || Used to facilitate insertion of the Aero-AL cage into the disc space.