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U.S. Department of Health and Human Services

Class 2 Device Recall SERFAS

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  Class 2 Device Recall SERFAS see related information
Date Initiated by Firm October 24, 2011
Date Posted November 21, 2011
Recall Status1 Terminated 3 on February 29, 2012
Recall Number Z-0265-2012
Recall Event ID 60301
510(K)Number K071859  
Product Classification electrosurgical device - Product Code GEI
Product Stryker Endoscopy 3.55 MM Super 90 S-SERFAS Energy Probe; electrosurgical device. Model number: 279-351-300;

Code Information Model number: 279-351-300; Lots 11161AE2 to 11241AE2, Lots are numbered sequentially using the middle three numbers, i.e 161-241.
Recalling Firm/
Manufacturer
Stryker Endoscopy
5900 Optical Ct
San Jose CA 95138-1400
For Additional Information Contact Michael Hillendoerfer
408-754-2664
Manufacturer Reason
for Recall
An increased number of complaints for tip breaks were observed for the 3.5mm Super 90-S SERFAS Energy Suction Probes manufactured from June to August 2011.
FDA Determined
Cause 2
Component design/selection
Action Stryker Endoscopy Urgent Medical Device Removal notifications datyed October 25, 2011, were sent to all consignees via traceable mail. Sales representatives and regional managers were notified by e-mail. Product is to be returned to Stryker Endoscopy using the pre-paid shipping label. Replacement product may be obtained by calling Stryker at 1-800-624-4422. The enclosed Acknowledgement receipt form is to be completed and returned. Questions or comments may be directed to Stryker at 1-800-624-4422 or e-mail at 90S@stryker.com.
Quantity in Commerce 6307
Distribution Worldwide distribution including USA, Australia, Canada, China, Greece, Hong Kong, India, Italy, Japan, France, Netherlands, Poland, South Africa, Spain, Sweden, Switzerland and the United Kingdom
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 = GEI and Original Applicant = Stryker Endoscopy
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