Device Recall Stryker

Catalog Number- 33250400S Catalog Number 33250360S

Orthopedic Devices

2

Yes

US Distribution including the states of IL, KY and TN.

GAMMA3 System Long Nail Kit, R2.0, Ti, Left || Distributed in USA by Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 USA || A single use device intended for the temporary fixation, correction of stabilization of the right femur. The kit consists of intramedullary nail and set screw. The kit is used in combination with lag screw and (distal) locking screws and end cap as well.

Code: M003450200, Lot 15391019, Expiration Date: 2015-07

Neurological Devices

HDE

Yes

International Distribution including Austria, China, and Germany.

Stryker brand Neuroform 3 Microdelivery Stent System, 4.5 mm X 20 mm, REF Catalog Number: E345020, Model/Product Number: M003450200, Product is manufactured by Boston Scientific Corporation, Fremont, CA and distributed by Stryker Neurovascular, Fremont, CA || The Neuroform Microdelivery Stent System is intended for use with embolic coils for the treatment of wide neck, intracranial, saccular aneurysms arising from a parent vessel with a diameter of greater than equal to 2 mm and greater than equal to 4.5 mm that are not amenable to treatment with surgical clipping.

K093670   Catalog numbers:  Small - 48551044 Medium - 48551045 Large - 48551046 Large Long - 48551047 Mini- 48551048  All lots of the above

Orthopedic Devices

2

Yes

Nationwide Distribution.

Stryker Oasys Midline Occiput Plate-1) Small 2) Medium 3) Large 4) Large Long || 5) Mini. || Allows for positioning directly on the midline keel of the occiput.

Product sold under the following part numbers: 0682001410A, 0682001410B, 0682001410C, 0682001410D, 0682001410E, 0682001410F, 0682001410G, and 0682001410H and shipped prior to February 28, 2013.

General Hospital and Personal Use Devices

1

No

Worldwide Distribution: US natiowide and to the country of Canada.

Stryker Visum 300 Ceiling-mounted Exam Light.

Catalog #6541-2-609 All lot codes

General and Plastic Surgery Devices

1

No

Nationwide Distribution

Stryker Howmedica Osteonics Triathlon tibial alignment ankle clamp extramedullary (EM) referencing instrument (Cat. No. 6541-2-609), for use in Total Knee Arthroplasty (TKA) when the surgeon elects to use Stryker's Triathlon Total Knee System in conjunction with EM referencing. Non-Sterile Instrument.