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U.S. Department of Health and Human Services

Class 2 Device Recall Empowr PS Knee Tibial Insert

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 Class 2 Device Recall Empowr PS Knee Tibial Insertsee related information
Date Initiated by FirmJanuary 10, 2017
Date PostedFebruary 03, 2017
Recall Status1 Terminated 3 on May 11, 2017
Recall NumberZ-1139-2017
Recall Event ID 76206
510(K)NumberK160342 
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
ProductEmpowr 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 ContactDesiree 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
ActionDJO 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 Commerce24 units
DistributionNationwide Distribution to CO, NY, and FL
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 = JWH
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