Encore Medical, LP: Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 7L 16MM, VE Model/Catalog Number: 341-16-707
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Encore Medical, LP
- Product
- Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 7L 16MM, VE Model/Catalog Number: 341-16-707
- Reason / hazard
- Knee and Humeral socket implants contain incorrect labeling.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- US Nationwide distribution in the states of VA, TN, IL, IN, MI, CO, WY, MT, RI, MA, NJ, PA, MO, OK, LA, FL, CA.
- Recall initiated
- 2026-01-15
- Code info
- Lot Code: Lot: 151T1055A GTIN: 00888912167147
- Product quantity
- 14 implants
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Austin
- State
- TX
- Country
- United States
- Event id
- 98340
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