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U.S. Department of Health and Human Services

Class 2 Device Recall Ability Dynamics

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  Class 2 Device Recall Ability Dynamics see related information
Date Initiated by Firm June 02, 2014
Date Posted June 18, 2014
Recall Status1 Terminated 3 on September 22, 2014
Recall Number Z-1825-2014
Recall Event ID 68535
Product Classification Assembly, knee/shank/ankle/foot, external - Product Code ISW
Product RUSH81 Prosthetic Foot

Product Usage: Prosthetic foot for human use
Code Information Serial Numbers: B1400045 B1400085 B1400272 B1400352 B1400101 B1400344 B1300083 B1400133 B1400114 B1300030 B1400290 B1400297 B1400197 B1400305 B1300043 B1400264 B1300080 B1400024 B1400087 B1300073 B1400108 B1400330 B1400138 B1300056 B1400261 B1400210 B1400321 B1400337 B1400300 B1400323 B1400351 B1400103 B1400104 B1400156 B1400173 B1400202 B1400222 B1400232 B1400253 B1400269 B1300062 B1400296 B1400258 B1400083 B1400111 B1300084 B1400135 B1400294 B1400031 B1400036 B1400162 B1300082 B1400102 B1400050 B1400051 B1400076 B1400084 B1300038 B1300025 B1400288 B1400280 B1400281 B1400312 B1400018 B1400252 B1400245 B1400260 B1400128 B1400201 B1400215 B1400308 B1400071 B1400033 B1400058 B1400213 B1400196 B1400214 B1400203 B1400204 B1400115 B1400212 B1400144 B1400319 B1400238 B1300072 B1300074 B1400336 B1400335 B1300061 B1400174 B1400175 B1400171 B1400194 B1300050 B1400059 B1400025 B1300036 B1400074 B1400089 B1400234 B1400346 B1400010 B1300065 B1400055 B1400064 B1300048 B1400151 B1400066 B1400090 B1400118 B1400119 B1400147 B1300029 B1300064 B1400227 B1400230 B1400231 B1400152 B1400153 B1300032 B1400216 B1400239 B1400241 B1400242 B1300075 B1400020 B1400298 B1400311 B1300023 B1400338 B1400340 B1400134 B1400143 B1400005 B1400289 B1300060 B1400105 B1400225 B1400332 B1400141 B1400154 B1400043 B1400098 B1400181 B1400318 B1400223 B1400220 B1400339 B1400182 B1400268 B1400334 B1300026 B1400049 B1400046 B1400047 B1400052 B1400249 B1400027 B1300047 B1300051 B1300053 B1400155 B1400310 B1400160 B1300079 B1300066 B1400015 B1400350 B1400273 B1400185 B1400250 B1400322 B1400061 B1300035 B1400168 B1300004 B1300005 B1300009 B1300010 B1300014 B1300015 B1300016 B1300020 B1400270 B1400271 
Recalling Firm/
Manufacturer		 Ability Dynamics LLC
2082 E University Dr
Tempe AZ 85281-4632
For Additional Information Contact
480-812-5123
Manufacturer Reason
for Recall		 Ability Dynamics is recalling RUSH81 Prosthetic Foot because the existing bolts may be bottomed out in the threaded hole and this could lead to bolt failure.
FDA Determined
Cause 2		 Device Design
Action Ability Dynamics sent an Urgent Medical Device Correction Notice letter dated June 2, 2014 to all affected customers (Prosthetist) who purchased the RUSH Prosthetic Foot. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to fill out the Bracket Bolt Replacement Form and return to Ability Dynamics. Customers with questions are instructed to contact Rich Sainz, National Clinical Manager, 2082 E. University Dr. Tempe AZ 85281 (480) 717-1412, rsainz@abilitydynamics.com.
Quantity in Commerce 175 units
Distribution Worldwide Distribution - US (nationwide) and in the countries of Australia and Canada.
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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