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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Disposable StrykeProbe 32cm LTip

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 Class 2 Device Recall Stryker Disposable StrykeProbe 32cm LTipsee related information
Date Initiated by FirmNovember 16, 2007
Date PostedMarch 05, 2008
Recall Status1 Terminated 3 on March 26, 2008
Recall NumberZ-0573-2008
Recall Event ID 45881
510(K)NumberK052141 
Product Classification Electrosurgical Suction Tip - Product Code GEI
ProductStryker Disposable StrykeProbe 32cm L- Tip, Ref: 250-070-550, Electrosurgical Suction Tip, Stryker Endoscopy, San Jose, CA 95138.
Code Information Lot Number: 07297FE2  
FEI Number 2936485
Recalling Firm/
Manufacturer		 Stryker Endoscopy
5900 Optical Ct
San Jose CA 95138
For Additional Information Contact
408-754-2124
Manufacturer Reason
for Recall		Cannot connect: Tips have electrodes that are too large to fit monopolar cables and are unusable.
FDA Determined
Cause 2		Device Design
ActionStryker notified their sales representatives by phone. Stryker sent all consignees a Product Advisory Notice dated November 19, 2007, and verbally notified them of the recall via telephone. A response form with return postage was sent with the notice. The letter requested the hospitals to quarantine and return the product to Stryker.
Quantity in Commerce59 boxes of 6 units (354 total)
DistributionNationwide 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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