Encore Medical, LP 2023-09-27 Health serious FDA
Health · FDA · Recall #FDA-Z-2603-2023
DJO Surgical: Empowr Knee, Universal Tibia Baseplate, 6R, REF: 352-02-106 Recall
Issued September 27, 2023 · Encore Medical, LP
In September 2023, Encore Medical, LP recalled the DJO Surgical: Empowr Knee, Universal Tibia Baseplate, 6R, REF: 352-02-106, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, which may require treatment, prolonged monitoring, and may lead to revision surgery
What you should do
- 1 Stop using DJO Surgical: Empowr Knee, Universal Tibia Baseplate, 6R, REF: 352-02-106 right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Encore Medical, LP to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Encore Medical, LP
- Category
- Health
- Recall date
- September 27, 2023
- Units affected
- Not reported
- Sold at
- US: AL, AZ, CA, CO, FL, IL, IN, KS, KY, LA, MA, MI, MN, MO, NC, NJ, NY, OH, PA, PR, RI, SC, TX, UT, VA, WA. OUS: Sweden, Australia, France,
- Recall number
- FDA-Z-2603-2023
- Made in
- United States
- Issuing agency
- FDA
In context
- Encore Medical, LP has 6 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.