DJO EMPOWR KNEE Femoral Sizer Recalled Due to Incorrect Assembly
Encore Medical is recalling 16 DJO EMPOWR KNEE Femoral Sizers because incorrect assembly caused the size-indicating windows to face the wrong direction.
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: The recall is classified as FDA Class II. The defect is a functional assembly error that impairs the device's usability but does not present an immediate risk of serious injury or death, fitting the criteria for a moderate severity recall.
Plain-English summary
Encore Medical, LP is recalling 16 units of the DJO EMPOWR KNEE Femoral Sizer (Model Number: 800-05-034, Lot Number: 326336L02). The recall was initiated because a vendor incorrectly assembled a subcomponent, resulting in the windows designed to show the size facing the opposite direction.
The affected units were distributed in the United States to Florida, Indiana, and Minnesota. No units were distributed outside the U.S.
The source text does not specify instructions for consumers or healthcare providers regarding the disposition of these devices.
The recalled product
- Product
- DJO EMPOWR KNEE Femoral Sizer
- Manufacturer
- Encore Medical, LP
- Affected units
- 16
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)
- Model Number: 800-05-034 Lot Number: 326336L02
Distribution
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