FDA Device Recall Z-0006-2007: Stryker Instruments Div. of Stryker Corporation

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0006-2007.

Recall Res Number

Z-0006-2007

Recalling Firm / Manufacturer

Stryker Instruments Div. of Stryker Corporation

FEI Number

1811755

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2006-09-08

Date Posted

2006-10-03

Date Terminated

2007-12-04

Product Code

HAW

Event Number

36214

Product Quantity

218 units for Recalls Z-0005/0008-2007

Product Description Stryker Navigation System Remote Planning Stations with Dell laptop computer model D800, Stryker # 7700-010-000 and 6000-300-000.

Reason for Recall A component of the device is a Dell laptop computer, which contains batteries that are under recall because they can overheat and cause a fire.

Action Details A recall letter dated 9/8/06 was sent to each customer instructing them to remove the battery from their Dell laptop computer model D800, to check the batteries to determine whether they are affected by the recall, and to only use the computer on AC power until they have requested and received replacement batteries.

Distribution Pattern Worldwide- USA and countries of Australia, Canada, France, Germany, Hong Kong, Italy, Japan, Mexico, New Zealand, South Korea, Switzerland and United Kingdom.

Code Information / Serial Numbers All units.

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Medical Device Recall: Z-0006-2007

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer