Z-2285-2025Class II

Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 4L 16MM, VE Model/Catalog...

Name: Z-2285-2025 Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 4L 16MM, VE Model/Catalog...
Creator: Encore Medical, LP
Published: 2025-07-09
License: https://open.fda.gov/license/

Encore Medical, LP / initiated 2025-07-09 / Open, Classified / root cause: labeling and UDI

FDA source

Encore Medical, LP began a recall of Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 4L 16MM, VE Model/Catalog Number: 341-16-704 Product Description: Enovis... on 2025-07-09. FDA classified it as Class II and gives the reason as "Knee implants contain incorrect labeling (size and/or side incorrect)". 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-2285-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-07-09
Posted: 2025-08-08
Recalling firm: Encore Medical, LP
Product: Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 4L 16MM, VE Model/Catalog Number: 341-16-704 Product Description: Enovis knee devices are intended for treatment of patients who are candidates for knee arthroplasty per the Indication for use. While total knee replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Knee implants contain incorrect labeling (size and/or side incorrect)
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: On January 15, 2026 Enovis (Encore Medical, L.P.) issued a Urgent: Medical Device Recall expansion notification to affected consignees via Email. The expansion notification included additional lots of affected product. Initial notification was sent out on July 9, 2025. Enovis asked consignees to take the following actions: 1. Review your stock for the products and lot numbers for the items to be returned. 2. Remove any indicated product from stock and quarantine. 3. This notice needs to be passed on to all those within your organization or to any organization where the product has been transferred. 4. Complete acknowledgement and response form and contact Customer Service at 1-800-456-8696 or through your regional email address, to place a replacement request. You will be provided with an RMA number and shipping label to return the affected product. 5. Return all devices (quantities listed above) using the RMA number and shipping label provided by Customer Service.
Quantity in commerce: 18 implants
Distribution: US Nationwide distribution in the states of AL, AZ, CA, CO, FL, IA, IL, IN, KS, LA, NY, TN, TX.
Product codes and lots: Lot Code: Item: 341-16-704 GTIN: 00888912167116 Lot\s: 148T1057

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2285-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2285-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-08-20	2025-08-08
Z-2286-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-08-20	2025-08-08

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)