Quick Facts at a Glance
- Recall Date
- January 5, 2026
- Hazard Level
- HIGH
- Brand
- Encore Medical, LP
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- Nationwide (50 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
- UDI-DI: 00888912167529. Lot: 139T1075A. Expiration: 03-12-2026
- Sold at
- Unknown
- Where affected
- Nationwide
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
January 5, 2026
Reported by FDA DEVICE
February 11, 2026
RecallRadar source check
February 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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.
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: N/A
About This Product
The EMPOWR 3D Knee Tibial Insert is designed for knee replacement surgeries. Patients typically receive this implant to replace damaged knee joints due to injury or arthritis.
Why This Is Dangerous
The packaging error may result in the wrong implant being used during surgery, leading to potential delays in procedures or the need for revision surgery.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients facing a surgical delay may experience prolonged discomfort and a longer recovery process.
Practical Guidance
How to identify if yours is affected
- Check the model number and lot number on the device packaging.
- Compare against the recall notice details provided by Encore Medical.
- Consult with your healthcare provider if unsure.
Where to find product info
The model number and lot number can typically be found on the device's packaging or accompanying documentation.
What timeline to expect
Expect a timeline of 4-6 weeks for processing refunds or replacements.
If the manufacturer is unresponsive
- Document all communications with Encore Medical.
- Follow up via phone or email.
- Consider reaching out to regulatory bodies if issues persist.
How to prevent similar issues
- Always verify product information before surgical procedures.
- Stay informed about product recalls related to medical devices.
- Consult with your healthcare provider about potential alternatives.
Documentation advice
Keep records of your device details, any correspondence with the manufacturer, and receipts if available.
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Product Details
The EMPOWR 3D Knee Tibial Insert 5R 14MM, REF: 342-14-705 was found to have a packaging discrepancy. It was distributed in various states including Texas, Iowa, and California since its recall date.
Key Facts
- Recall date: January 5, 2026
- Quantity recalled: 19 units
- Packaging error may cause surgical delays
- Contact Encore Medical for instructions
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Safety Guide
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