DJO EMPOWR Knee System Recall: Incorrect Device in Packaging
Encore Medical is recalling 37 DJO surgical EMPOWR Porous Knee System SIZE 8 devices distributed nationwide because incorrect product components were packaged with certain units.
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 an FDA Class II recall involving a medical device where incorrect packaging creates a risk-of-harm situation. Although no illnesses or injuries have been reported, the potential for serious complications from device mismatch meets the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Encore Medical, LP is recalling 37 DJO surgical EMPOWR Porous Knee System devices due to incorrect product/device components within the packaging. The affected devices include Model 243-01-108 (Lot 277W1114) and Model 353-03-108 (Lot 213W1051), both SIZE 8 Left configurations. These devices were distributed nationwide throughout the United States and are intended for knee arthroplasty (total knee replacement) in eligible patients.
When incorrect surgical components are packaged with devices, healthcare providers may receive and potentially implant the wrong component, which could lead to surgical complications or additional procedures.
Healthcare facilities and patients who received affected units should verify the contents of their packages before use. Any person who believes they received an incorrect device should contact Encore Medical, LP immediately. Additional information is available through the FDA.
The recalled product
- Product
- DJO surgical EMPOWR Porous Knee System Empowr 3D Femur-Porous Coated SIZE 8 Left 3D MATRIX COATED REF 243-01-108 DJO surgical EMPOWR KNEE", PRESS FIT BP MINUS, 8L REF 353-03-108 For the treatment of patients who are candidates for knee arthroplasty per the Indication for us
- Manufacturer
- Encore Medical, LP
- Hazard
- device-mismatch
- packaging-error
Distribution
Distributed nationwide across the United States.
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