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 |
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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.
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510(K) Database | 510(K)s with Product Code = GEI
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