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Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS recallZ-2285-2025 · Encore Medical, LP · initiated Jul 9, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Encore Medical, LP or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Knee implants contain incorrect labeling (size and/or side incorrect)

FDA root cause category: Labeling Change Control

What the company is doing

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.

Recall details

Recall number
Z-2285-2025
Status
Open, Classified
Initiated by the company
Jul 9, 2025
Posted by the FDA
Aug 8, 2025
Recalling firm
Encore Medical, LP
Quantity
18 implants
Product code
JWH
FDA submissions
K143242
Distribution
US Nationwide distribution in the states of AL, AZ, CA, CO, FL, IA, IL, IN, KS, LA, NY, TN, TX.

Product description

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.

Code information (models, lots, serial numbers)

Lot Code: Item: 341-16-704 GTIN: 00888912167116 Lot\s: 148T1057

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

25 devices cleared under K143242 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 97188).

Sources and updates

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