Stryker Instruments Navigation System II PC SPC-1 Assembly, Stryker Navigation, Kalamazoo, MI; REF 7700-101-201. The Stryker Navigation System II is a computer-aided surgery platform, supporting surgeons to perform surgical interventions.
FDA Recall Z-0123-2010 · Posted 2009-11-20
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Recalling FirmStryker Instruments Div. of Stryker Corporation
Recall StatusTerminated
Product CodeHAW
Date Initiated2009-10-26
Date Terminated2009-12-31
Product Quantity2 replacement systems
Reason for Recall
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.
Firm Action
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.
Root Cause
Software design
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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