Recall Z-0123-2010 ยท HAW Neurological Stereotaxic Instrument
Stryker Instruments Div. of Stryker Corporation
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.
| Date | Nov 20, 2009 (initiated Oct 26, 2009) |
| Status | Terminated |
| Reason | 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 | Software design |
| 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 |
| Quantity | 2 replacement systems |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K993239 | STRYKER NAVIGATION SYSTEM - NEURO MODULE, MODEL 6000-XXX-XXX Stryker Corp., Jan 18, 2000 |