EMPOWR 3D Knee surgical device recalled due to packaging discrepancy
Encore Medical, LP is recalling EMPOWR 3D KNEE surgical devices due to a packaging discrepancy where incorrect product sizes were mixed up in packaging.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II device recall with a packaging labeling discrepancy. The source text does not report any illnesses, injuries, or adverse events. The hazard is a potential risk (wrong implant size used) rather than confirmed harm, placing it in the Moderate category per the rubric.
Plain-English summary
Encore Medical, LP is recalling EMPOWR 3D KNEE surgical devices due to a packaging discrepancy. Incorrect product sizes were mixed up in packaging, which could result in the wrong implant size being used during knee arthroplasty surgery.
The affected devices are EMPOWR 3D KNEE INS units in various configurations (11L 14MM, 3R 19MM, and 11R 14MM) with model numbers 342-19-703, 342-19-703, and 342-14-711. The recalled units include lot code 177T1057, 135T1060, and 145T1067. Distribution occurred across multiple states through authorized distributors including Certus Medical LLC (Indiana and Michigan), Fox Medtech, LLC (Colorado, Wyoming, Montana, and Nebraska counties), Implant Medical Sales, Inc. (New York), Joint Medical Solutions, L.L.C. (Alabama), Great Lakes Medical (Illinois), Matrix Orthopedics Surgical Devices (Dallas/Fort Worth, Texas), Kinetic Medicine (South Dakota, Eastern Nebraska, and Western Iowa), and ProCore Medical LLC (North Carolina).
If you have received or used one of these devices, contact your authorized distributor or Encore Medical, LP immediately. Healthcare facilities should verify that the correct device size was used during any surgical procedures and consult with Encore Medical regarding appropriate steps.
The recalled product
- Product
- Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number: 342-19-703 Product Description: Enovis knee devices are intended for knee arthroplasty.
- Manufacturer
- Encore Medical, LP
- Affected units
- 4
Distribution
Part of a larger recall action
This product is one of 2 recalled by Encore Medical, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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