Stryker Operating Room System II Surgical Navigation System - Recall

Date of Recall

2009-11-27

Recall Details

Recall Class: Class I

Date Recall Initiated:  October 26, 2009

Product:  Operating Room System II Surgical Navigation Systems

Product Name	Stryker Catalog Number	Serial#/Lot# Range
Navigation System II-Cart	7700-100-000	Serial #s 100715-100735
PC SPC-1 Assembly	7700-101-201	Lot # K7P00F6000

These devices were manufactured from March 31, 2009 through July 16, 2009 and distributed from March 31, 2009 though July 28, 2009.

Use: 

The Navigation System II is a computer-aided surgery platform that surgeons use to perform hip, knee, spine, neurology, and ears, nose and throat surgery.  It contains a computer workstation that includes computer programs (software) and various components necessary to run the system.

Recalling Firm:

Stryker Instruments, a division of Stryker Corporation
4100 Milham Avenue
Kalamazoo, Michigan  49001

Reason for Recall:  

The device may suddenly stop working, the screen may freeze, or the information may only be updated very slowly.  These problems may affect all software products.  These failures could result in delay in surgery, rescheduling of the procedure resulting in an additional surgery, risk of infection, increased disease symptoms, potential neurological problems, or injury due to the surgeon operating in an area where they did not intend to operate.  Depending on the type of surgery, these failures could potentially lead to serious adverse health consequences, including death.   

Public Contact:  

Customers should report any adverse events or product quality problems to Stryker Instruments by calling 1-800-253-3210, Monday – Friday, 8:00 A.M. – 7:00 P.M. (Eastern Time)

For more information, see Useful Links below.

FDA District:  Detroit

FDA Comments: 

Hospitals that have the products with the above catalog numbers should stop using the product, immediately quarantine the product, and label it as a recalled product.  As of October 30, 2009, the company corrected all U.S. units.

On November 4, 2009, the company sent a letter to their customers informing them about the affected products, the reason for recall, the recall plan, and the actions to take.

The company requested that their customers take the following actions:

• Review the letter and distribute it to all departments that are affected.
• Quarantine immediately any affected product and label each one as a recalled product.
• Complete and sign the enclosed reply form and fax a copy to the company.
• Wait for the company’s Field Service Representative to schedule the repair of the equipment.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of these products to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.

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