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U.S. Department of Health and Human Services

Class 2 Device Recall Thoracic Pedicle Feeler instrument is intended for use with the Stryker Navigation System.

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  Class 2 Device Recall Thoracic Pedicle Feeler instrument is intended for use with the Stryker Navigation System. see related information
Date Initiated by Firm October 16, 2017
Create Date March 27, 2018
Recall Status1 Terminated 3 on April 03, 2019
Recall Number Z-1216-2018
Recall Event ID 79335
510(K)Number K012380  
Product Classification Neurological stereotaxic Instrument - Product Code HAW
Product The Stryker Thoracic Pedicle Feeler 6002-350-000 is a smart instrument for remote control of
the navigation software and creation of a pathway into the pedicle. The instrument has three
types of buttons to remotely control the software: the UP, DOWN and SELECT buttons. The
Pedicle Feeler is laser marked in 10 mm intervals to help indicate the depth in which the feeler
tip has been inserted into the pedicle. Next to the navigational information, these depth
indicators on the feeler tip are also helpful in determining the appropriate pedicle screw length.
Code Information Serial Number(s) Affected: 10897, 10898, 10899, 10900, 10901, 10902, 10903, 10904, 10905, 10906, 10907, 10908, 10909, 10910, 10911, 10912, 10913, 10914, 10917, 10919, 10920, 10921, 10922, 10923, 10925, 10926, 10927, 10928. Product Code (UDI): (01)04546540503824
Recalling Firm/
Manufacturer		 Stryker Instruments Div. of Stryker Corporation
4100 E Milham Ave
Portage MI 49002-9704
Manufacturer Reason
for Recall		 Stryker Instruments and Stryker Leibinger GmbH & Co. KG are voluntarily recalling certain serial numbers Thoracic Pedicle Feelers that are used in conjunction with the Stryker¿ Navigation System because the settings on the machine were higher than intended. This change led to increased energy directed onto the tip of the Thoracic Pedicle Feeler which caused material degradation where the laser marks exist. There is the potential for the tip of the Thoracic Pedicle Feeler to break.
FDA Determined
Cause 2		 Software Manufacturing/Software Deployment
Action US customers will be notified via FedEx overnight. US Sales Representatives will be notified via email. International entities will be notified via an internal notification system. International customers will be notified per local regulations/procedures. Customer Instructions: Actions to be taken by the Customer/User: 1. Immediately review this Recall Notification. 2. Immediately check all stock areas and/or operating room storage for affected equipment. Quarantine and discontinue use of any affected Thoracic Pedicle Feelers. 3. Complete the enclosed Business Reply Form (BRF) to confirm receipt of this Notification and identify how many affected items are currently in your inventory. Please complete and return the BRF even if you don't have any affected product on hand. Note: Your signature on the BRF indicates that you received and understand this Notification and have followed the instructions in the Notification. 4. If you have further distributed this product, please forward this Notification and the attached BRF to all affected locations. Please indicate each location on the BRF. 5. If the BRF for your facility indicates that recalled product is currently on hand, we will contact you to arrange for the return of the product for repair/replacement. If discontinuing use of the specific Thoracic Pedicle Feeler(s) listed will cause disruption at your facility. For further questions, please call (269) 323-7700.
Quantity in Commerce 28
Distribution International , US and US Govt.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HAW and Original Applicant = STRYKER LEIBINGER
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