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U.S. Department of Health and Human Services

Class 2 Device Recall AC wall adapter for use with battery powered upper limb prosthesis.

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  Class 2 Device Recall AC wall adapter for use with battery powered upper limb prosthesis. see related information
Date Initiated by Firm February 01, 2005
Date Posted July 06, 2005
Recall Status1 Terminated 3 on October 07, 2008
Recall Number Z-0959-05
Recall Event ID 32060
Product Classification Hand, External Limb Component, Powered - Product Code IQZ
Product Spectre brand AC wall adapter to be used with ProControl 2 or ProHand battery powered upper limb prosthesis.
Code Information Part number PD1880 PL6A
Recalling Firm/
Manufacturer		 Motion Control, Inc.
2401 S 1070 W Ste B
Salt Lake City UT 84119
For Additional Information Contact
801-978-2622
Manufacturer Reason
for Recall		 Incorrect AC wall adapter was distributed with prostheses. Incorrect use of adapters could damage the battery and cause a potential fire hazard.
FDA Determined
Cause 2		 Other
Action Consignees were notified by phone and letter on 2/3/2005.
Quantity in Commerce 20 units
Distribution CA, DC, FL, NJ, OH, PA, SC, TN, TX, and Puerto Rico. No military, government or foreign distribution.
Total Product Life Cycle TPLC 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.
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