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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Implants & Prosthetics

EMPOWR Acetabular System and Knee Inserts Recalled for Packaging Errors

Agency Publication Date: February 2, 2026
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Summary

Encore Medical, LP is recalling 68 units of EMPOWR 3D Knee Tibial Inserts and Acetabular System liners due to a packaging discrepancy. Some packages were found to contain the wrong surgical component, such as a size 36H liner being found inside a box labeled for a size 40G liner. This issue affects various models distributed across 14 U.S. states and Puerto Rico, and it could lead to surgical delays while staff exchange the device or even require revision surgery if the error is not caught before implantation.

Risk

The packaging error may lead to the selection of the wrong size or model of surgical implant during a procedure. This can result in extended time under anesthesia while the correct device is located, or the need for a second surgery (revision) if the incorrect component is implanted.

What You Should Do

  1. Stop using the recalled devices immediately.
  2. Identify affected products by checking the REF (catalog) numbers, Lot numbers, and UDI-DI codes on the medical device packaging. Affected items include EMPOWR 3D Knee Tibial Inserts (REF: 342-14-705) and EMPOWR Acetabular System liners (REF: 942-01-36H, 942-01-36J, 942-01-40G, 942-01-32C). See the Affected Products section below for the full list of affected codes.
  3. Contact the manufacturer or your distributor to arrange for the return, replacement, or correction of any affected units in your inventory.
  4. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions or to report adverse events.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: EMPOWR 3D Knee Tibial Insert 5R 14MM, VE
Variants: 5R 14MM
Model / REF:
342-14-705
Lot Numbers:
139T1075A (Exp 03-12-2026)
UDI:
00888912167529

Recall #: Z-1233-2026

Product: EMPOWR Acetabular System: Liner, 10 degree Hooded, HXe+
Variants: 36H, 36J, 40G, 32C, 10 degree Hooded
Model / REF:
942-01-36H
942-01-36J
942-01-40G
942-01-32C
Lot Numbers:
624Z1032 (Exp 03-15-2026)
626Z1021 (Exp 03-15-2026)
628Z1034 (Exp 03-15-2026)
615Z1026 (Exp 03-15-2026)
UDI:
00190446309789
00190446309802
00190446309826
00190446309697

Recall #: Z-1234-2026

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98177
Status: Active
Manufacturer: Encore Medical, LP
Sold By: Hospitals; Surgical Centers; Medical Device Distributors
Manufactured In: United States
Units Affected: 2 products (19; 49)
Distributed To: Texas, Iowa, Michigan, Mississippi, Massachusetts, Rhode Island, New Jersey, Pennsylvania, New York, Missouri, Oklahoma, Puerto Rico, Alabama, California

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.