Z-1139-2017Class II

Empowr PS Knee Tibial Insert; Model 343-14-709 The EMPOWR PS tibial insert are made from Highly Cross-Linked...

Name: Z-1139-2017 Empowr PS Knee Tibial Insert; Model 343-14-709 The EMPOWR PS tibial insert are made from Highly Cross-Linked...
Creator: Encore Medical, Lp
Published: 2017-01-10
License: https://open.fda.gov/license/

Encore Medical, LP / initiated 2017-01-10 / Terminated / root cause: design

FDA source

Encore Medical, Lp began a recall of 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... on 2017-01-10. FDA classified it as Class II and gives the reason as "The Empowr PS Insert was reported as missing the impaction slot feature". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1139-2017
Classification: Class II
Status: Terminated
Initiated: 2017-01-10
Posted: 2017-02-03
Terminated: 2017-05-11
Recalling firm: Encore Medical, LP
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.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: The Empowr PS Insert was reported as missing the impaction slot feature.
Root cause tag: design
FDA root cause: 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
Product codes and lots: 035U1000

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1139-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1139-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-15	2017-02-03

Product code JWH

K160342Class IIEMPOWR PS Knee SystemEncore Medical L.P. / cleared 2016-05-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)