Z-1233-2026Class II

EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705

Name: Z-1233-2026 EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705
Creator: Encore Medical, LP
Published: 2026-01-05
License: https://open.fda.gov/license/

Encore Medical, LP / initiated 2026-01-05 / Open, Classified / root cause: labeling and UDI

FDA source

Encore Medical, LP began a recall of EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705 on 2026-01-05. FDA classified it as Class II and gives the reason as "942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cause surgical delay...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1233-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-01-05
Posted: 2026-02-02
Recalling firm: Encore Medical, LP
Product: EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: 942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cause surgical delay to exchange devices or revision surgery.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: On 1/5/2026, recall notices were emailed to customers who were asked to do the following: 1) This notice needs to be passed on to all those within your organization or to any organization where the product has been transferred. 2) Contact the firm to arrange for affected device return. 3. Complete and return the acknowledgement and response form via email to [email protected] Customers with questions can email the firm at [email protected]
Quantity in commerce: 19
Distribution: US: TX, IA, MI, MS, MA, RI, NJ, PA, NY, MO, OK, PR, AL, CA
Product codes and lots: UDI-DI: 00888912167529. Lot: 139T1075A. Expiration: 03-12-2026

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1233-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1233-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-11	2026-02-02
Z-1234-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-11	2026-02-02

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)