Z-0327-2018Class II

EMPOWR Porous Knee System TIBIAL PUNCH, SMALL, REF 801-05-202, NON STERILE, Qty 1 For use in orthopedic...

Name: Z-0327-2018 EMPOWR Porous Knee System TIBIAL PUNCH, SMALL, REF 801-05-202, NON STERILE, Qty 1 For use in orthopedic...
Creator: Encore Medical, Lp
Published: 2017-12-12
License: https://open.fda.gov/license/

Encore Medical, LP / initiated 2017-12-12 / Terminated / root cause: design

FDA source

Encore Medical, Lp began a recall of EMPOWR Porous Knee System TIBIAL PUNCH, SMALL, REF 801-05-202, NON STERILE, Qty 1 For use in orthopedic surgery on 2017-12-12. FDA classified it as Class II and gives the reason as "The Locking Punch Guide was not sufficiently guiding the large press fit punch, causing the implant to be placed 2-3mm more posterior than intended". 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-0327-2018
Classification: Class II
Status: Terminated
Initiated: 2017-12-12
Posted: 2018-01-10
Terminated: 2022-06-13
Recalling firm: Encore Medical, LP
Product: EMPOWR Porous Knee System TIBIAL PUNCH, SMALL, REF 801-05-202, NON STERILE, Qty 1 For use in orthopedic surgery.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: The Locking Punch Guide was not sufficiently guiding the large press fit punch, causing the implant to be placed 2-3mm more posterior than intended.
Root cause tag: design
FDA root cause: Device Design
Action: The field safety notice was disseminated by email on 12/12/2017. The notice stated the following: "DJO Sales Agents Action: Please review the bulletin that is provided with this notice. This bulletin contains new instructions on the use of the Locking Punch Guide and Punch. Please ensure your surgeons are familiar with this information. DJO Surgical then requires that you complete the attached acknowledgment and email it to [email protected]. Please have this form returned by December 15, 2017 Once redesigned guides are available, they will be exchanged through a separate field action."
Quantity in commerce: 2 units
Distribution: One medical device distributor in California.
Product codes and lots: Lot 252564

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0327-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0326-2018	Class II	Terminated	Voluntary: Firm initiated	2018-01-17	2018-01-10
Z-0327-2018	Class II	Terminated	Voluntary: Firm initiated	2018-01-17	2018-01-10
Z-0328-2018	Class II	Terminated	Voluntary: Firm initiated	2018-01-17	2018-01-10
Z-0329-2018	Class II	Terminated	Voluntary: Firm initiated	2018-01-17	2018-01-10

Product code JWH

K100900Class IIMotivation Knee SystemEncore Medical L.P. / cleared 2010-06-18

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)