Lower risk Medical device recall · FDA · Published January 5, 2026

Encore Medical EMPOWR 3D Knee Tibial Insert 5R 14MM Recall: Packaging Discrepancy Risk

Encore Medical recalls EMPOWR 3D Knee Tibial Insert 5R 14MM (REF: 342-14-705) due to packaging discrepancies that may cause surgical delays. Affected units have specific lot numbers and expiration dates.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1233-2026Medical device Encore Medical ›

Lower-risk recall

942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cause surgical delay to exchange devices or revision surgery.

Take action

Contact the company

Recalling firmEncore Medical, LP9800 Metric Blvd · Austin, TX 78758-5445

✎ GovInfoNow plain-language explainer

Encore Medical is recalling EMPOWR 3D Knee Tibial Insert 5R 14MM (REF: 342-14-705) because packaging discrepancies could delay surgery or require revision procedures. This affects patients who have received this specific implant. Read more at govinfonow.com/recall/50319-encore-medical-empowr-3d-knee-tibial-insert-5r-14mm-recall.

Source Summary by GovInfoNow · govinfonow.com/recall/50319-encore-medical-empowr-3d-knee-tibial-insert-5r-14mm-recall · Updated August 17, 2026 · FDA enforcement record: FDA #Z-1233-2026

Cite this page

“Encore Medical EMPOWR 3D Knee Tibial Insert 5R 14MM Recall: Packaging Discrepancy Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/50319-encore-medical-empowr-3d-knee-tibial-insert-5r-14mm-recall. Based on FDA recall #Z-1233-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1233-2026%22&limit=1).

The FDA announced on 2026-01-05 that Encore Medical, LP is recalling EMPOWR 3D Knee Tibial Insert devices due to a packaging discrepancy. The error may cause surgical delays by requiring device exchanges or revision surgery.

How to tell if you have it

Brand: Encore Medical
Product: EMPOWR 3D Knee Tibial Insert 5R 14MM, VE
REF: 342-14-705
UDI-DI: 00888912167529
Lot: 139T1075A
Expiration: 03-12-2026

The hazard

The FDA said the 942-01-40G acetabular system package was found to contain a 942-01-36H acetabular system. Several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cause surgical delay to exchange devices or revision surgery.

Context

GovInfoNow's records show Encore Medical, LP has 43 other recalls on record since 2017-05-31. Recent brand recalls include the 2026-02-16 EMPOWR 3D KNEE Ins 11L 14MM VE packaging mix-up and the 2026-01-15 EMPOWR 3D KNEE Implants incorrect labeling notice. Other recent recalls of similar products include the 2026-07-13 Straumann GM Helix Dental Implant Recall and the 2026-08-12 Straumann GM Helix Implant Recall.

How to tell if you have this one

Check for the product code REF: 342-14-705, lot number 139T1075A, and expiration date 03-12-2026 on the packaging. This specific implant is used in knee replacement surgeries.

Brand
Encore Medical
Category
Medical device

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
US: TX, IA, MI, MS, MA, RI, NJ, PA, NY, MO, OK, PR, AL, CA

Recall number	Product, codes & lots	Quantity
Z-1233-2026	EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705; UDI-DI: 00888912167529. Lot: 139T1075A. Expiration: 03-12-2026	19
Z-1234-2026	EMPOWR Acetabular System: Liner, 10 degree Hooded, HXe+, 36H, REF: 942-01-36H; Liner, 10 degree Hooded, HXe+, 36J, REF: 942-01-36J; Liner, 10 degree Hooded, HXe+, 40G, REF: 942-01-40G; Liner, 10 degree Hooded, HXe+, 32C, REF: 942-01-32C; REF/UDI-DI/Lot(Expiration): 942-01-36H/00190446309789/624Z1032(03-15-2026), 942-01-36J/00190446309802/626Z1021(03-15-2026), 942-01-40G/00190446309826/628Z1034(03-15-2026), 942-01-32C/00190446309697/615Z1026(03-15-2026)	49

Based on the official FDA remedy

What to do — step by step

Check Product Details
Verify the product code REF: 342-14-705, lot number 139T1075A, and expiration date 03-12-2026 on the packaging.

Where it went and when

Where it was distributed

Distributed in 13 states and Puerto Rico.

FDA distribution: “US: TX, IA, MI, MS, MA, RI, NJ, PA, NY, MO, OK, PR, AL, CA” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, California, Iowa, Massachusetts, Michigan, Mississippi, Missouri, New Jersey, New York, Oklahoma, Pennsylvania, Puerto Rico, Rhode Island, Texas.

Recall timeline

FDA published this recall 37 days after the firm started it.

Jan 5, 2026Firm started the recall
Feb 2, 2026FDA classified it Class II
Feb 11, 2026Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/50319-encore-medical-empowr-3d-knee-tibial-insert-5r-14mm-recall">Encore Medical EMPOWR 3D Knee Tibial Insert 5R 14MM Recall: Packaging Discrepancy Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1233-2026 (January 5, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1233-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.