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 Empowr PS Knee Tibial Insert

  • 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 Empowr PS Knee Tibial Insert see related information
Date Initiated by Firm January 10, 2017
Date Posted February 03, 2017
Recall Status1 Terminated 3 on May 11, 2017
Recall Number Z-1139-2017
Recall Event ID 76206
510(K)Number K160342  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product Empowr PS Knee Tibial Insert; Model 343-14-709
The EMPOWR PS tibial insert are made from Highly Cross-Linked Vitamin E (HXL VE) UHMWPE. The tibial insert implants are intended to mate with tibial base implants.
Code Information 035U1000
Recalling Firm/
Manufacturer		 Encore Medical, Lp
9800 Metric Blvd
Austin TX 78758-5445
For Additional Information Contact Desiree Wells
512-832-9500
Manufacturer Reason
for Recall		 The Empowr PS Insert was reported as missing the impaction slot feature.
FDA Determined
Cause 2		 Component design/selection
Action DJO Global sent an Urgent Field Safety Notice dated January 10, 2017, to all affected customers. The Field Safety Notice instructs the agents to notify all individuals within their organization or to any organization where the potentially affected product has been transferred. Customers with questions should contact customer service at 1-800-456-8696. For questions regarding this recall call 512-832-9500.
Quantity in Commerce 24 units
Distribution Nationwide Distribution to CO, NY, and FL
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 = JWH and Original Applicant = Encore Medical, L.P.
-
-