Quick Facts at a Glance
- Recall Date
- January 15, 2026
- Hazard Level
- HIGH
- Brand
- Encore Medical, LP
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Encore Medical, LP
- Product type
- Knee Implant
- Model numbers
- Lot Code: Lot: 151T1055A GTIN: 00888912167147
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
January 15, 2026
Reported by FDA DEVICE
March 4, 2026
RecallRadar source check
March 11, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Knee and Humeral socket implants contain incorrect labeling.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Encore Medical, LP or your healthcare provider for instructions. Notification method: Letter
About This Product
The EMPOWR 3D Knee implant is designed for patients requiring knee replacement surgery. Surgeons and healthcare providers choose this product for its advanced design and compatibility with various surgical techniques.
Why This Is Dangerous
Incorrect labeling on the knee and humeral socket implants can result in improper usage, potentially leading to ineffective treatment or adverse effects.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients may face delays in necessary treatments while addressing the recall, potentially affecting their recovery timeline.
Practical Guidance
How to identify if yours is affected
- Check the model number on your implant to confirm if it is 341-16-707.
- Verify the lot code against the recalled lot code 151T1055A.
- Contact your healthcare provider for assistance in identifying affected products.
Where to find product info
The model number and lot code can typically be found on the packaging or the implant itself, as indicated by your surgeon.
What timeline to expect
Expect a response or instruction from Encore Medical within a few weeks after reporting the recall.
If the manufacturer is unresponsive
- Document all attempts to contact the manufacturer.
- Reach out to your healthcare provider for assistance.
- Consider filing a complaint with the FDA if unresponsive.
How to prevent similar issues
- Inquire about labeling and safety certifications when selecting medical devices.
- Stay informed about product recalls related to medical implants.
- Discuss with your healthcare provider any concerns about the devices being used.
Documentation advice
Keep copies of all correspondence with Encore Medical and your healthcare provider, including any instructions you receive regarding the recall.
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Product Details
The recalled product is the EMPOWR 3D KNEE INS, 7L 16MM, VE with model number 341-16-707. The affected lot code is Lot: 151T1055A and GTIN: 00888912167147. This product was distributed nationwide across several states, including Virginia, Tennessee, and California.
Key Facts
- Recall date: January 15, 2026
- Class II recall status
- Distributed in 15 states across the US
- Immediate action required for patients and providers
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Safety Guide
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