Stryker Navigation System - iNtellect Cranial Planning Software - Enable, Part number 6000-652-300. It is part of the pr

FDA device recall Z-1409-2011 · posted 2011-02-25 · Terminated

Recall details

Recalling firm

Stryker Instruments Division of Stryker Corporation

Reason for recall

When users imports more than one image set and changes the viewing direction for both images, the orientation of every other image series might be stored incorrectly, as a mirror image. This may lead to insufficient or inaccurate correlation results or incorrectly shown orientation of every second image series during navigation.

Action taken

Urgent: Medical Device Recall Notification letters were sent on 12/3/2010, and software upgrades were to be performed in the field by the end of 2010. Specific Customer Instructions: 1) Locate the units listed in the notification. 2) Distribute this notification to all departments affected. 3) Return the enclosed business reply form to confirm receipt of this notification and identify how many affected units are currently in your inventory. 4) Once the new software is available, Stryker will dispatch a service tech in order to update the software. Note: Software upgrades for all applications will be available by the end of the year. The upgrades will be scheduled as we receive your business reply form. Note: If you currently have a Time License or Pay Per Use card, a new one will be issued to you at the time of the update. 5) If you have loaned or sold any of the units listed in this notification, please, forward a copy of this notice to the new users and advise Stryker of the new users name and their new location. 6) If you have disposed of any of the affected units and they are no longer in use, please, advise us of their obsolescence by providing us with their serial numbers. Questions regarding this recall should be directed to Stryker Field Action Team at 800-800-4236, ext 3808, 3584, or 4354 between the hours of 8 a.m. - 5 p.m. Monday - Friday.

Root cause

Software design

Status

Terminated

Product code

HAW

Quantity affected

1,155 total

Distribution

Worldwide Distribution -- USA, Canada, Mexico, Australia, Argentina, Brazil, United Kingdom, Japan, Poland, S. Korea, Hong Kong, Taiwan, India, and New Zealand.

Date initiated

2010-11-10

Date posted

2011-02-25

Date terminated

2011-06-01

Location

Kalamazoo, MI

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