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Terminated

Stryker Navigation System, eNlite System with Dell laptop computer model D800, Stryker # 7700-300-000.

FDA Recall Z-0005-2007 · Posted 2006-10-03

Recalling FirmStryker Instruments Div. of Stryker Corporation
Recall StatusTerminated
Product CodeHAW
Date Initiated2006-09-08
Date Terminated2007-12-04
Product Quantity218 units for Recalls Z-0005/0008-2007

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.

Firm Action

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.

Root Cause

Other

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K004027STRYKER REMOTE SURGICAL PLANNING SYSTEMStryker Instruments · 2001-01-24K993239STRYKER NAVIGATION SYSTEM - NEURO MODULE, MODEL 6000-XXX-XXXStryker Corp. · 2000-01-18

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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