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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 FirmFebruary 01, 2005
Date PostedJuly 06, 2005
Recall Status1 Terminated 3 on October 07, 2008
Recall NumberZ-0959-05
Recall Event ID 32060
Product Classification Hand, External Limb Component, Powered - Product Code IQZ
ProductSpectre 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
ActionConsignees were notified by phone and letter on 2/3/2005.
Quantity in Commerce20 units
DistributionCA, DC, FL, NJ, OH, PA, SC, TN, TX, and Puerto Rico. No military, government or foreign distribution.
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.
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