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U.S. Department of Health and Human Services

Class 2 Device Recall Point Setter

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 Class 2 Device Recall Point Settersee related information
Date Initiated by FirmFebruary 27, 2009
Date PostedMay 11, 2012
Recall Status1 Terminated 3 on May 22, 2012
Recall NumberZ-1539-2012
Recall Event ID 52454
510(K)NumberK984355 
Product Classification Endoscope, neurological - Product Code GWG
ProductMitaka Point Setter, holding system for surgical instruments. Holding surgical instruments during operating procedures.
Code Information Inddivdual Serial Numbers - 18 total: 70952; 70972; 71002; 71012; 71022; 71032; 71042; 71052; 71062; 71082; 71102; 71112; 71122; 71142; 81162; 81172; 81182; 81192.
FEI Number 3002996788
Recalling Firm/
Manufacturer		 Mitaka USA, Inc.
2337 Lucky John Dr
Park City UT 84060-6914
For Additional Information ContactMax Sturgis
435-649-2236
Manufacturer Reason
for Recall		Use of a potentially weaker spring in the device than required to meet specifications to hold the Point Setter ARM in place during surgery.
FDA Determined
Cause 2		Component design/selection
ActionMitaka USA sent a letter dated to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. The letter included instructions for returning the product. Contact the Customer Support Department at 800-421-0837, ext. 7577 for questions regarding this notice.
Quantity in Commerce18 units (3 internationally and 15 within the U.S.)
DistributionWorldwide Distribution-USA (nationwide) including the states of AZ, FL, CA, SC, OH, WA, TX, VA, MI, MO, GA, and NC and the country of Canada.
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 = GWG
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