Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall UCPLUS Solution

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall UCPLUS Solution see related information
Date Initiated by Firm July 18, 2006
Date Posted November 16, 2006
Recall Status1 Terminated 3 on December 13, 2007
Recall Number Z-0191-2007
Recall Event ID 36237
510(K)Number K982859  
Product Classification Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer - Product Code HRY
Product UC-PLUS Solution Unicondylar Knee System, Model Numbers: 26004 Femoral Component Size 4, 26006
Femoral Component Size 6, 26008 Femoral Component Size 8 and 26010 Femoral Component Size 10
Code Information Lot Number: All lots considered affected Serial Number: None
Recalling Firm/
Manufacturer		 Plus Orthopedics USA
10188 Telesis Ct
San Diego CA 92121-4779
For Additional Information Contact Clint Corona
888-741-7587 Ext. 2513
Manufacturer Reason
for Recall		 There exists the possibility that incomplete bony support or insufficient cementing of the implanted device can result in fatigue fracture of the UC-PLUS Solution Femoral Component.
FDA Determined
Cause 2		 Other
Action The 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 Commerce 68
Distribution California
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.
510(K) Database 510(K)s with Product Code = HRY and Original Applicant = PLUS ORTHOPEDICS
-
-