EMPOWR 3D Knee Insert E-Plus: Incorrect Labeling Risk
Encore Medical recalls EMPOWR 3D Knee TIBIAL INSERT E-PLUS (model 341-16-704) due to incorrect labeling of size and side. This may lead to improper implant fitting.
Lower-risk recall
Knee implants contain incorrect labeling (size and/or side incorrect)
Contact the company
What happened, in plain English
Encore Medical is recalling EMPOWR 3D Knee TIBIAL INSERT E-Plus models with incorrect labeling of size and side. This could cause improper fitting during knee replacement surgery, potentially leading to complications. Read more at govinfonow.com/recall/51825-empowr-3d-knee-insert-e-plus-incorrect-labeling-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/51825-empowr-3d-knee-insert-e-plus-incorrect-labeling-risk · Updated August 17, 2026 · FDA enforcement record: FDA #Z-2285-2025
Cite this page
“EMPOWR 3D Knee Insert E-Plus: Incorrect Labeling Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51825-empowr-3d-knee-insert-e-plus-incorrect-labeling-risk. Based on FDA recall #Z-2285-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2285-2025%22&limit=1).
Why it’s dangerous
The knee implant has incorrect labeling of size and side, which could lead to improper fitting during surgery. This might cause complications such as misalignment or improper joint function after the procedure.
Who’s affected
Patients who received the EMPOWR 3D Knee TIBIAL INSERT E-Plus (model 341-16-704) during knee replacement surgery are affected. Surgeons and medical staff who used this model are most at risk.
How to tell if you have this one
Check for the model number 341-16-704 on the product label. This specific knee implant was sold with lot code 148T1057.
- Brand
Encore Medical- Product
Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 4L 16MM, VE Model/Catalog Number- Category
Medical device
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 Nationwide distribution in the states of AL, AZ, CA, CO, FL, IA, IL, IN, KS, LA, NY, TN, TX.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-2285-2025 | Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 4L 16MM, VE Model/Catalog Number: 341-16-704 Product Description: Enovis knee devices are intended for treatment of patients who are candidates for knee arthroplasty per the Indication for use. While total knee replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients.; Lot Code: Item: 341-16-704 GTIN: 00888912167116 Lot\s: 148T1057 | 18 implants |
| Z-2286-2025 | Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 7R 16MM, VE Model/Catalog Number: 342-16-707 Product Description: Enovis knee devices are intended for treatment of patients who are candidates for knee arthroplasty per the Indication for use. While total knee replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients.; Lot Code: Item: 342-16-707 GTIN: 00888912167642 Lot: 161T1053, 161T1054 | 40 implants |
What to do — step by step
Check Product Label
Look for the model number 341-16-704 on the implant label.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 13 states.
FDA distribution: “US Nationwide distribution in the states of AL, AZ, CA, CO, FL, IA, IL, IN, KS, LA, NY, TN, TX.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, California, Colorado, Florida, Illinois, Indiana, Iowa, Kansas, Louisiana, New York, Tennessee, Texas.
Recall timeline
FDA published this recall 42 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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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-2285-2025 (July 9, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2285-2025 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.