Z-0325-2017Class II

Empowr PS Knee System Box Cut Guide; Used to make the housing resection for the post of the posterior...

Name: Z-0325-2017 Empowr PS Knee System Box Cut Guide; Used to make the housing resection for the post of the posterior...
Creator: Encore Medical, Lp
Published: 2016-09-19
License: https://open.fda.gov/license/

Encore Medical, LP / initiated 2016-09-19 / Terminated / root cause: design

FDA source

Encore Medical, Lp began a recall of Empowr PS Knee System Box Cut Guide; Used to make the housing resection for the post of the posterior stabilized implant on 2016-09-19. FDA classified it as Class II and gives the reason as "It has been discovered that during Empowr PS Total Knee replacement, while chiseling for bone removal in the box area, femoral chipping has occurred in surgery. The current design of the captured box cut guides can...". 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-0325-2017
Classification: Class II
Status: Terminated
Initiated: 2016-09-19
Posted: 2016-10-28
Terminated: 2017-10-20
Recalling firm: Encore Medical, LP
Product: Empowr PS Knee System Box Cut Guide; Used to make the housing resection for the post of the posterior stabilized implant.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: It has been discovered that during Empowr PS Total Knee replacement, while chiseling for bone removal in the box area, femoral chipping has occurred in surgery. The current design of the captured box cut guides can create an instance where the surgeon is not fully completing the box cut on the side.
Root cause tag: design
FDA root cause: Under Investigation by firm
Action: The recalling firm sent a recall notification letter to affected consignees on 9/19/16. The field safety notice provided a newly revised Surgical Technique to educate users on proper use of the device.
Quantity in commerce: 436 units
Distribution: US
Product codes and lots: 202351L01, 202434L01, 203779L01, 202351L02, 202434L02, 202351L03, 202434L03, 203779L03, 202351L04, 202434L04, 202351L05, 202434L05, 202351L06, 202434L06, 203779L06, 202351L07, 202434L07, 203779L07, 202351L08, 202434L08, 203779L08, 202351L09, 202434L09, 202351L10, 202434L10, 203203L01

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0325-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0325-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-09	2016-10-28

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)