| Class 2 Device Recall Olympus Trocar Spikes |  |
Date Initiated by Firm | February 08, 2010 |
Date Posted | March 18, 2010 |
Recall Status1 |
Terminated 3 on May 25, 2010 |
Recall Number | Z-1163-2010 |
Recall Event ID |
54634 |
510(K)Number | K790071 K923982 |
Product Classification |
Endoscope and/or accessories - Product Code KOG
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Product | Olympus Trocar Spikes, Model numbers: A5821, A5948, A5949, WA58341L, and WA58343L
Used in conjunction with a compatible trocar tube, trocar tubes are used for intraperitoneal access during laparoscopic access during laparoscopic applications, and enable the passage of endoscopes and other diagnostic and therapeutic tools through the abdominal wall. |
Code Information |
Lot numbers: 075W, 076W, 077W, 078W, 081W, 083W, 084W, 07XW, and 07YW |
Recalling Firm/ Manufacturer |
Olympus America Inc. 3500 Corporate Pkwy. P.O. Box 610 Center Valley PA 18034-0610
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For Additional Information Contact | Customer Service 800-848-9024 |
Manufacturer Reason for Recall | weak weld seams |
FDA Determined Cause 2 | Nonconforming Material/Component |
Action | The recalling firm issued a Medical Device Recall letter dated February 8, 2010, informing their customers of the problem and the need to return the product. |
Quantity in Commerce | 45 |
Distribution | Nationwide: AL, AR, CA, FL, MI, MN, MO, NY, PA, OH, TX, and WY. Foreign: Canada |
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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 = KOG
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