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EMPOWR 3D Knee Tibial Insert, 5R 16MM, VE, REF: 342-16-705 recallZ-0766-2025 · Encore Medical, LP · initiated Dec 18, 2024

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

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.

FDA root cause category: Labeling Change Control

What the company is doing

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]

Recall details

Recall number
Z-0766-2025
Status
Open, Classified
Initiated by the company
Dec 18, 2024
Posted by the FDA
Dec 26, 2024
Recalling firm
Encore Medical, LP
Quantity
33
Product code
JWH
FDA submissions
K143242
Distribution
US Nationwide distribution in the states of VA, MN, TX, WI, IA, IL, IN, SC, NY, MD, CA, FL, AZ, WA.

Product description

EMPOWR 3D Knee Tibial Insert, 5R 16MM, VE, REF: 342-16-705; EMPOWR 3D Knee Tibial Insert, 3R 14MM, VE, REF: 342-14-703

Code information (models, lots, serial numbers)

REF/UDI-DI/Lot: 342-16-705/00888912167628/159T1086 342-14-703/00888912167505/137T1086

Devices named in this recall

2 devices 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.

Sources and updates

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