Knee Implant Packaging Error Could Lead to Wrong Device Implantation
Encore Medical is recalling EMPOWR 3D Knee Tibial Inserts due to packaging discrepancies that could result in incorrect implants being selected during surgery. Patients may require revision surgery if the wrong implant is used.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a FDA Class II recall with no reported injuries or illnesses. However, the packaging error creates a risk-of-harm situation where incorrect implants could be selected, potentially requiring revision surgery. Per the rubric, recalls with risk of harm but no reported injury are classified as High.
Plain-English summary
Encore Medical, LP is recalling EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS devices due to a packaging discrepancy in which incorrect tibial inserts or implants were packaged together. This error could result in the wrong product being selected during knee replacement surgery.
The recall affects 20 units distributed to medical facilities in Arizona, Idaho, Illinois, Indiana, Iowa, Louisiana, Michigan, Missouri, Mississippi, Nebraska, New York, Oklahoma, Oregon, Puerto Rico, South Dakota, Utah, Virginia, and Washington. The affected lot is 071T1084.
If a patient receives the incorrect implant, revision surgery may be necessary. Patients who have undergone knee replacement surgery using a device from this lot should contact their healthcare provider or surgeon to confirm the correct implant was used.
Healthcare providers and patients with questions should contact Encore Medical, LP directly.
The recalled product
- Product
- Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L 10MM, VE Model/Catalog Number: 341-10-711 Software Version: NA Product Description: Enovis" knee devices are intended for treatment of patients who are candidates for knee arthroplasty p
- Manufacturer
- Encore Medical, LP
- Hazard
- packaging-error
- wrong-implant
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Code: Item: 341-10-711 GTIN: 00888912166881 Lot\s: 071T1084
Distribution
Distributed in 18 states:
- AZ
- IA
- ID
- IL
- IN
- LA
- MI
- MO
- MS
- NE
- NY
- OK
- OR
- PR
- SD
- UT
- VA
- WA
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