Date Initiated by Firm | November 16, 2007 |
Date Posted | March 05, 2008 |
Recall Status1 |
Terminated 3 on March 26, 2008 |
Recall Number | Z-0574-2008 |
Recall Event ID |
45881 |
510(K)Number | K052141 |
Product Classification |
Electrosurgical Suction Tip - Product Code GEI
|
Product | Stryker Disposable StrykeProbe 32cm Spatula Tip, Ref: 250-070-551, Electrosurgical Suction Tip, Stryker Endoscopy, San Jose, CA 95138. |
Code Information |
Lot Number: 07298FE2 |
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 |
Action | Stryker 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 Commerce | 8 boxes of 6 units (48 total) |
Distribution | Nationwide Distribution. |
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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