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Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS recallZ-2125-2025 · Encore Medical, LP · initiated Jun 2, 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

Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. The use of this product may result in the incorrect product being selected. This could result in a revision surgery if used.

FDA root cause category: Packaging change control

What the company is doing

On 06/02/2025, the firm emailed an "Urgent: Medical Device Recall" letter to customers. The letter described the product, problem and actions to be taken. Customers are instructed to: 1.Review their stock for the products and lot numbers for the items to be returned. 2.This notice needs to be passed on to all those within their organization or to any organization where the product has been transferred. 3.Complete acknowledgement and response form and contact Customer Service at 1-800-456-8696 or through their regional email address, to place a replacement request. They will be provided with an RMA number and shipping label to return the affected product. 4.Return all devices (quantities listed above) using the RMA number and shipping label provided by Customer Service. Any questions, contact Recall Coordinator at [email protected] or call/text 682-299-9133.

Recall details

Recall number
Z-2125-2025
Status
Open, Classified
Initiated by the company
Jun 2, 2025
Posted by the FDA
Jul 17, 2025
Recalling firm
Encore Medical, LP
Quantity
20
Product code
JWH
FDA submissions
K143242
Distribution
U.S Distribution to states of: AZ, IA, ID, IL, IN, LA, MI, MO, MS, NE, NY, OK, OR, PR, SD, UT, VA, and WA

Product description

Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L 10MM, VE Model/Catalog Number: 341-10-711 Software Version: NA 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. Component: NA

Code information (models, lots, serial numbers)

Lot Code: Item: 341-10-711 GTIN: 00888912166881 Lot\s: 071T1084

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 97048).

Sources and updates

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