Z-0041-2018Class II

EMPOWR PS KNEE(TM) e+, REF 343-13-708, SIZE 8, 13mm, QTY 01, SKY BLUE, STERILE Product Usage The EMPOWR PS...

Name: Z-0041-2018 EMPOWR PS KNEE(TM) e+, REF 343-13-708, SIZE 8, 13mm, QTY 01, SKY BLUE, STERILE Product Usage The EMPOWR PS...
Creator: Encore Medical, Lp
Published: 2017-09-15
License: https://open.fda.gov/license/

Encore Medical, LP / initiated 2017-09-15 / Terminated / root cause: packaging

FDA source

Encore Medical, Lp began a recall of EMPOWR PS KNEE(TM) e+, REF 343-13-708, SIZE 8, 13mm, QTY 01, SKY BLUE, STERILE Product Usage The EMPOWR PS Inserts are manufactured from ultra high molecular... on 2017-09-15. FDA classified it as Class II and gives the reason as "It was reported that an implant labeled as 343-13-708 was packaged with implant 343-19-707". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0041-2018
Classification: Class II
Status: Terminated
Initiated: 2017-09-15
Posted: 2017-10-20
Terminated: 2023-08-29
Recalling firm: Encore Medical, LP
Product: EMPOWR PS KNEE(TM) e+, REF 343-13-708, SIZE 8, 13mm, QTY 01, SKY BLUE, STERILE Product Usage The EMPOWR PS Inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) infused with pure liquid pharmaceutical grade alpha-tocopheral and then cross-linked to conform to ASTM F2695. This insert is posterior stabilized and is intended to more closely match the kinematics of the knee, allowing some rotation along the medial condyle and increased congruency along the lateral condyle.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: It was reported that an implant labeled as 343-13-708 was packaged with implant 343-19-707.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: The firm initiated the recall by email on 09/05/2017. The letter identified the affected product, problem and actions to be taken. The consignee was directed to notify anyone to whom the product was transferred and to return any in-stock product.
Quantity in commerce: 48 units
Distribution: US Nationwide Distribution
Product codes and lots: Lot Number 287U1004

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0041-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0041-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-01	2017-10-20
Z-0042-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-01	2017-10-20

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)