Z-0711-2017Class II

Empowr Knee System

Name: Z-0711-2017 Empowr Knee System
Creator: Encore Medical, Lp
Published: 2016-11-15
License: https://open.fda.gov/license/

Encore Medical, LP / initiated 2016-11-15 / Terminated / root cause: labeling and UDI

FDA source

Encore Medical, Lp began a recall of Empowr Knee System Product Usage: Non-porous proximal tibial baseplate implants, utilized in either posterior cruciate ligament (PCL) retaining or PCL... on 2016-11-15. FDA classified it as Class II and gives the reason as "A size 4 Empowr baseplate was mislabeled as a size 6. The affected lot was laser marked as M6, marked with the lot number for the size 6 minus lot, and distributed as size 6 minus". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0711-2017
Classification: Class II
Status: Terminated
Initiated: 2016-11-15
Posted: 2016-12-06
Terminated: 2017-01-20
Recalling firm: Encore Medical, LP
Product: Empowr Knee System Product Usage: Non-porous proximal tibial baseplate implants, utilized in either posterior cruciate ligament (PCL) retaining or PCL substituting total knee arthroplasty procedure.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: A size 4 Empowr baseplate was mislabeled as a size 6. The affected lot was laser marked as M6, marked with the lot number for the size 6 minus lot, and distributed as size 6 minus.
Root cause tag: labeling and UDI
FDA root cause: Mixed-up of materials/components
Action: The recalling firm sent an Urgent Field Safety Notice letter dated November 15, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. For questions call 760-734-3551.
Quantity in commerce: 7 units
Distribution: US Nationwide Distribution in the states of CO, IL, IN, FL, CA, AZ
Product codes and lots: 033T1022

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0711-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0711-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-14	2016-12-06

Product code JWH

K143242Class IIRebel 3DKNEE SystemEncore Medical L.P. / cleared 2015-05-15

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)