Empowr 3D Knee Insert (Unknown) – Labeling Error (2025)
Incorrect labeling may compromise accurate identification of knee implants.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 4L 16MM, VE Model/Catalog Number: 341-16-704 Software Version: NA 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. Compone
Lot Codes / Batch Numbers
Lot Code: Item: 341-16-704 GTIN: 00888912167116 Lot\s: 148T1057
Products Sold
Lot Code: Item: 341-16-704 GTIN: 00888912167116 Lot\s: 148T1057
A medical device manufacturer is recalling Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 4L 16MM, VE due to Knee implants contain incorrect labeling. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Knee implants contain incorrect labeling
Recommended Action
Per FDA guidance
On July 9, 2025 Enovis (Encore Medical, L.P.) issued a Urgent: Medical Device Recall notification to affected consignees via Email. Enovis asked consignees to take the following actions: 1. Review your stock for the products and lot numbers for the items to be returned. 2. Remove any indicated product from stock and quarantine. 3. This notice needs to be passed on to all those within your organization or to any organization where the product has been transferred. 4. Complete acknowledgement and response form and contact Customer Service at 1-800-456-8696 or through your regional email address, to place a replacement request. You will be provided with an RMA number and shipping label to return the affected product. 5. Return all devices (quantities listed above) using the RMA number and shipping label provided by Customer Service.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026