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EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705 recallZ-1233-2026 · Encore Medical, LP · initiated Jan 5, 2026

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

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.

FDA root cause category: Labeling Change Control

What the company is doing

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]

Recall details

Recall number
Z-1233-2026
Status
Open, Classified
Initiated by the company
Jan 5, 2026
Posted by the FDA
Feb 2, 2026
Recalling firm
Encore Medical, LP
Quantity
19
Product code
JWH
FDA submissions
K143242
Distribution
US: TX, IA, MI, MS, MA, RI, NJ, PA, NY, MO, OK, PR, AL, CA

Product description

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

Code information (models, lots, serial numbers)

UDI-DI: 00888912167529. Lot: 139T1075A. Expiration: 03-12-2026

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 98177).

Sources and updates

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