Device product
Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 4L 16MM, VE Model/Catalog Number: 341-16-704 Product Description: Enovis knee devices are intended for treatment of patients who are candidates for knee arthroplasty per the Indication for use. While total knee replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients.
Z-2285-2025
Product summary
- Event
- Event 97188
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 18 implants
- Official record key
device-enforcement:Z-2285-2025
Official wording
Reason: Knee implants contain incorrect labeling (size and/or side incorrect)
Code information: Lot Code: Item: 341-16-704 GTIN: 00888912167116 Lot\s: 148T1057
Distribution pattern: US Nationwide distribution in the states of AL, AZ, CA, CO, FL, IA, IL, IN, KS, LA, NY, TN, TX.
Derived failure modes
-
Labeling or packaging
labeling (size and/or side incorrect