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DJO surgical EMPOWR Porous Knee System Empowr 3D… recallZ-0508-2024 · Encore Medical, LP · initiated Nov 10, 2023

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 incorrect product/device within packaging.

FDA root cause category: Labeling Change Control

Recall details

Recall number
Z-0508-2024
Status
Open, Classified
Initiated by the company
Nov 10, 2023
Posted by the FDA
Dec 7, 2023
Recalling firm
Encore Medical, LP
Quantity
37 devices
Product code
MBH
FDA submissions
K171991
Distribution
US Nationwide distribution.

Product description

DJO surgical EMPOWR Porous Knee System Empowr 3D Femur-Porous Coated SIZE 8 Left 3D MATRIX COATED REF 243-01-108 DJO surgical EMPOWR KNEE", PRESS FIT BP MINUS, 8L REF 353-03-108 For the treatment of patients who are candidates for knee arthroplasty per the Indication for use.

Code information (models, lots, serial numbers)

Model Number: 243-01-108 UDI-DI Code: 00190446231295 Lot Number: 277W1114 Model Number: 353-03-108 UDI-DI Code: 00190446231295 Lot Number: 213W1051

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

44 devices cleared under K171991 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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