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U.S. Department of Health and Human Services

Class 2 Device Recall UCPLUS Solution

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 Class 2 Device Recall UCPLUS Solutionsee related information
Date Initiated by FirmJuly 18, 2006
Date PostedNovember 16, 2006
Recall Status1 Terminated 3 on December 13, 2007
Recall NumberZ-0192-2007
Recall Event ID 36237
510(K)NumberK032052 
Product Classification Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer - Product Code HRY
ProductUC-PLUS Solution Unicondylar Knee System, Model Numbers: 26014 Femoral Component Size 4, 26016 Femoral Component Size 6, 26018 Femoral Component Size 8 and 26020 Femoral Component Size 10
Code Information 26014: Lot number 0305.13.2814, 26016: Lot number 0305.13.2815, 26018: Lot number 0305.13.2816, 26020: Lot number 0305.13.2817 Serial Number: None
Recalling Firm/
Manufacturer
Plus Orthopedics USA
10188 Telesis Ct
San Diego CA 92121-4779
For Additional Information ContactClint Corona
888-741-7587 Ext. 2513
Manufacturer Reason
for Recall
The modified devices were distributed by Plus Orthopedics USA (Plus USA) June 10, 2003 prior to FDA approval to market of the modified device (Special 510(k) K032052, clearance date July 25, 2003) and withdrawn from the field June 25, 2003.
FDA Determined
Cause 2
Other
ActionThe depth of the withdrawal action taken in June, 2003 was to the distributor (agent) level. Plus USA contacted individual agent sites showing inventory of the affected article numbers on hand and requested that those items be returned to Plus USA.
Quantity in Commerce12
DistributionCalifornia
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 = HRY
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