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U.S. Department of Health and Human Services

Class 2 Device Recall Olympus Trocar Spikes

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 Class 2 Device Recall Olympus Trocar Spikessee related information
Date Initiated by FirmFebruary 08, 2010
Date PostedMarch 18, 2010
Recall Status1 Terminated 3 on May 25, 2010
Recall NumberZ-1163-2010
Recall Event ID 54634
510(K)NumberK790071 K923982 
Product Classification Endoscope and/or accessories - Product Code KOG
ProductOlympus 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
For Additional Information ContactCustomer Service
800-848-9024
Manufacturer Reason
for Recall
weak weld seams
FDA Determined
Cause 2
Nonconforming Material/Component
ActionThe 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 Commerce45
DistributionNationwide: AL, AR, CA, FL, MI, MN, MO, NY, PA, OH, TX, and WY. Foreign: Canada

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 = KOG
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