EMPOWR 3D KNEE insertion instruments recalled for incorrect product size packaging
Encore Medical is recalling EMPOWR 3D KNEE insertion instruments because some packages contain incorrect product sizes due to a packaging discrepancy.
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 recall involving a packaging error with incorrect product sizes. No illnesses or injuries have been reported, and the hazard is a labeling/packaging discrepancy rather than a contamination or safety defect, making it a moderate-severity voluntary precautionary recall.
Plain-English summary
Encore Medical, LP is recalling EMPOWR 3D KNEE insertion instruments (Model/Catalog Numbers 341-14-711 and 342-14-711, also referenced as 342-19-703) used for knee arthroplasty. The devices are being recalled due to a packaging discrepancy in which incorrect product sizes were mixed into packages.
The recalled devices were distributed to medical facilities in multiple states including Indiana, Michigan, Colorado, Wyoming, Montana, Nebraska, New York, Alabama, Illinois, Texas, South Dakota, Iowa, and North Carolina. Affected lot codes include 145T1067 and 135T1060.
Healthcare providers and patients who have received these devices should verify that the product size in the package matches the intended surgical size. Contact Encore Medical or the distributor if a discrepancy is identified.
The recalled product
- Product
- Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number: 341-14-711 Product Description: Enovis knee devices are for knee arthroplasty.
- Manufacturer
- Encore Medical, LP
- Affected units
- 8
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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