Z-0766-2025Class II

EMPOWR 3D Knee Tibial Insert, 5R 16MM, VE, REF: 342-16-705; EMPOWR 3D Knee Tibial Insert, 3R 14MM, VE, REF...

Name: Z-0766-2025 EMPOWR 3D Knee Tibial Insert, 5R 16MM, VE, REF: 342-16-705; EMPOWR 3D Knee Tibial Insert, 3R 14MM, VE, REF...
Creator: Encore Medical, LP
Published: 2024-12-18
License: https://open.fda.gov/license/

Encore Medical, LP / initiated 2024-12-18 / Open, Classified / root cause: labeling and UDI

FDA source

Encore Medical, LP began a recall of EMPOWR 3D Knee Tibial Insert, 5R 16MM, VE, REF: 342-16-705; EMPOWR 3D Knee Tibial Insert, 3R 14MM, VE, REF: 342-14-703 on 2024-12-18. FDA classified it as Class II and gives the reason as "5R 16MM knee tibial insert package may contain knee tibial insert 3R 14MM and vice versa, which may cause surgical delay to get a new product". 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-0766-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-12-18
Posted: 2024-12-26
Recalling firm: Encore Medical, LP
Product: EMPOWR 3D Knee Tibial Insert, 5R 16MM, VE, REF: 342-16-705; EMPOWR 3D Knee Tibial Insert, 3R 14MM, VE, REF: 342-14-703
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: 5R 16MM knee tibial insert package may contain knee tibial insert 3R 14MM and vice versa, which may cause surgical delay to get a new product.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: On 12/18/2024, recall notices were emailed to consignees 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. Review your stock for the products and lot numbers for the items to be returned. 3. Return all devices (quantities listed above) using the RMA number and shipping label provided by Customer Service. 4. Complete and return the acknowledgement and response form via email to [email protected] If you have questions contact the firm at [email protected]
Quantity in commerce: 33
Distribution: US Nationwide distribution in the states of VA, MN, TX, WI, IA, IL, IN, SC, NY, MD, CA, FL, AZ, WA.
Product codes and lots: REF/UDI-DI/Lot: 342-16-705/00888912167628/159T1086 342-14-703/00888912167505/137T1086

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0766-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0766-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-01	2024-12-26

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)