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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Stiletto Electrosurgical Probe (EProbe)

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 Class 2 Recall
Stryker Stiletto Electrosurgical Probe (EProbe)
see related information
Date Posted March 17, 2011
Recall Status1 Terminated on March 18, 2011
Recall Number Z-1704-2011
Recall Event ID 55617
Premarket Notification
510(K) Number
K052141 
Product Classification Electrosurgical, Cutting & Coagulation & Accessories - Product Code GEI
Product Stryker Stiletto Electrosurgical Probe (E-Probe); Model number: 0270-070-550, 0270-070-551, 0270-070-552, 0270-070-553, 0270-070-554, 0270-070-555; Manufactured by Stryker Endoscopy Puerto Rico.
Code Information 09158FE2, 09161FE2, 09164FE2, 09170FE2, 09174FE2, 09176FE2, 09219FE2, 09226FE2, 09233FE2, 09339FE2, 09264FE2, 09204FE2, 09205FE2, 09210FE2, 09211FE2, 09217FE2, 09120FE2, 09170FE2, 09181FE2, 09181FE2P, 09175FE2, 09209FE2, and 09167FE2.
Recalling Firm/
Manufacturer
Stryker Endoscopy
5900 Optical Ct
San Jose, California 95138-1400
For Additional Information Contact Nila Patel
408-754-2124
Manufacturer Reason
for Recall
The heat shrink, PTFE E-Probe Tip were out of specification (OOS) in the longitudinal change (+5% -20%).
FDA Determined
Cause 2
DESIGN: Device Design
Action All Sales reps were notified of the recall on February 25, 2010. Urgent Device Removal advisory notices were also sent to all consignees.Device Removal letters identified the specific part numbers and lot numbers involved. Letters also list the potential risk to patients as a result of the issue. Customers are asked to inspect their inventory for part and lot numbers and quarantine any affected product. If recalled product is found, customers are to contact Stryker Customer Service at 800-624-4422 and request an RMS to send back recalled units. New units will be provided at no charge. The acknowledgement form is to be completed and returned. Questions or concerns should be directed to 408-754-2000 or e-mail at eprobe@stryker.com.
Quantity in Commerce 31, 014 units
Distribution Worldwide Distribution -- US, Australia, Canada, Germany, Greece, Iberia, Korea, Switzerland, and Newbury.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GEI and Original Applicant = Stryker Endoscopy
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