Skip to content

EMPOWER 3D Knee Tibial Insert, REF: 341-14-708. Orthopedic… recallZ-0126-2023 · Encore Medical, LP · initiated Aug 12, 2022

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

Hip liner implant boxes may contain knee inserts and knee insert boxes may contain hip liner implants, which may lead to implants not being available for surgeries, which may cause delays in surgery.

FDA root cause category: Process control

What the company is doing

On 8/12/22, recall notices were emailed to DJO Surgical Agents who were informed to do the following: 1) Pass the notice to all those within your organization or to any organization where the potentially affected devices have been transferred. 2) Return affected devices 3) Complete and return the response form Questions, contact: [email protected]

Recall details

Recall number
Z-0126-2023
Status
Open, Classified
Initiated by the company
Aug 12, 2022
Posted by the FDA
Oct 21, 2022
Recalling firm
Encore Medical, LP
Quantity
18
Product code
LPH
FDA submissions
K143242
Distribution
US Nationwide distribution in the states of FL, IN, IL, KY, AZ, TX.

Product description

EMPOWER 3D Knee Tibial Insert, REF: 341-14-708. Orthopedic implant component.

Code information (models, lots, serial numbers)

UDI-DI/Lot: 00888912167055/132T1085

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 90882).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page