—#86038

Product

Stryker Instruments Navigation System II- CART, Stryker Navigation, Kalamazoo, MI; Stryker REF 7700-100-000. Intended to be used as a component of the Navigation System II.

FDA product code: HAW — Neurological Stereotaxic Instrument
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K993239
Affected lot / code info: Serial number range 100715 through 100735.

Why it was recalled

Multiple software-related malfunctions may occur. The device may suddenly stop working, the screen may freeze, the screen may only be updated very slowly, the unit may not respond to user input, or the unit may only respond to user very slowly.

Root cause (FDA determination)

Software design

Action the firm took

The firm issued a press release on 11/4/09. Consignees were notified by an Urgent: Medical Device Recall Notification letter dated 10/23/09, which advised of the affected products, the reason for the recall, the recall plan, and the actions to be taken. Customers were to immediately review this notification and distribute to all departments affected. Also, customers were to immediately quarantine any affected product and label as recalled product; complete and sign the enclosed Business Reply Form and fax a copy to 866-521-2762. Upon receipt of the form, a Stryker Navigation Field Service Rep would contact them to schedule the repair of their equipment. All U.S. units were corrected by 10/30/09.

Recalling firm

Firm: Stryker Instruments Div. of Stryker Corporation
Address: 4100 E. Milham Ave., Kalamazoo, Michigan 49001

Distribution

Distribution pattern: Worldwide Distribution -- USA, including states of Florida, Kansas, Kentucky, Massachusetts, Michigan, New Jersey, Pennsylvania, South Carolina, Texas, and Washington and countries of Australia, China, Germany, Japan, Korea, Switzerland, and the United Kingdom.

Timeline

Recall initiated: 2009-10-26
Posted by FDA: 2009-11-20
Terminated: 2009-12-31
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #86038. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.