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EMPOWR Acetabular System, Liner, 10 Hooded, HXe+, 40H, REF:… recallZ-0103-2024 · Encore Medical, LP · initiated Aug 22, 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

Knee insert and acetabular system parts were swapped within inner pack prior to the product being sealed within the tray, which could result in surgeons not having the correct product for the surgery due to different anatomies (Hip vs Knee).

FDA root cause category: Labeling Change Control

What the company is doing

On 8/22/23, recall notices were emailed to agents who were asked to do the following: 1) Complete acknowledgement and response form and contact Customer Service at 1-800-456-8696 to place a replacement order and receive an RMA number. 2) The notice needs to be passed on to all those within your organization or to any organization where the potentially affected product has been transferred. If you have any questions, email [email protected]

Recall details

Recall number
Z-0103-2024
Status
Open, Classified
Initiated by the company
Aug 22, 2023
Posted by the FDA
Oct 12, 2023
Recalling firm
Encore Medical, LP
Quantity
20
Product code
LPH
FDA submissions
K190057
Distribution
US Nationwide distribution in the states of FL, CA, IN, HI, LA, MN, AZ, TX, NJ, PA, KS, TN, PR, SC, WA.

Product description

EMPOWR Acetabular System, Liner, 10 Hooded, HXe+, 40H, REF: 942-01-40H

Code information (models, lots, serial numbers)

UDI-DI: 00190446309833, Lot: 629Z1114, Expiration: March 30, 2028

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

73 devices cleared under K190057 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 93098).

Sources and updates

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