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U.S. Department of Health and Human Services

Class 2 Device Recall 3.5mm Super 90S SERFAS Energy Suction Probe

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 Class 2 Device Recall 3.5mm Super 90S SERFAS Energy Suction Probesee related information
Date Initiated by FirmJune 20, 2008
Date PostedFebruary 09, 2009
Recall Status1 Terminated 3 on June 22, 2009
Recall NumberZ-0972-2009
Recall Event ID 50825
510(K)NumberK041810 
Product Classification Electrosurgical Cutting & Coagulation & Accessories - Product Code GEI
ProductStryker Endoscopy brand 3.5mm Super 90-S SERFAS Energy Suction Probe; Model Number: 279-351-300; Manufactured By: Stryker Endoscopy, Puerto Rico
Code Information 08065AE2, 08066AE2, 08070AE2, 08079AE2, 08084AE2, 08086AE2, 08080AE2, 08085AE2, 08087AE2, 08088AE2, 08129AE2, 08128AE2, 08130AE2, 08136AE2, 08137AE2, 08140AE2, 08149AE2, 08154AE2, and 08157AE2
Recalling Firm/
Manufacturer		 Stryker Endoscopy
5900 Optical Ct
San Jose CA 95138-1400
For Additional Information ContactJennifer Scott
408-754-2124
Manufacturer Reason
for Recall		The probes may have inadequate suction due to obstruction, which can result in unintended ablation due to reduced visibility within the surgical area.
FDA Determined
Cause 2		Process control
ActionOn 6/20/08, the firm initiated the recall and its notification was via Urgent: Device Removal letters explaining the reason for the recall. The letter recommended that recipients of the letter inspect their inventory for the part number/lot numbers listed and quarantine any of the affected product. Affected products should be returned to Stryker Endoscopy using the Pre-paid shipping label provided. Customers should call Stryker Endoscopy's Customer Service Department at 1-800-624-4422 for replacement product. Importantly, customers should sign and complete the enclosed "acknowledgment of receipt" card and return it to Stryker Endoscopy or fax it to 408-754-2521 with the customer's account info included. If there are any questions regarding the notice, a Regulatory Affairs Representative should be contacted at 408-754-2161 or 408-754-2000.
Quantity in Commerce2463 units
DistributionWorldwide Distribution.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = GEI
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