Knee and Humeral Socket Implants Recalled for Incorrect Labeling
Encore Medical, LP is recalling 14 EMPOWR 3D KNEE implants because they contain incorrect labeling. The recall affects US nationwide distribution.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which per the rubric warrants a score of 4 (Severe) when hospitalization reports or significant injury are present. The source text does not mention any reported illnesses or injuries, but the FDA Class II classification places this recall in the Severe category.
Plain-English summary
Encore Medical, LP is recalling 14 EMPOWR 3D KNEE INS, 7L 16MM, VE implants, model number 341-16-707, lot code 151T1055A. The implants contain incorrect labeling, according to the recall notice.
The recall was classified as Class II by the FDA, meaning the product could cause temporary or medically reversible adverse health consequences if used as labeled.
The recalled implants were distributed nationwide in the states of VA, TN, IL, IN, MI, CO, WY, MT, RI, MA, NJ, PA, MO, OK, LA, FL, and CA.
Healthcare providers and recipients should contact Encore Medical, LP regarding the incorrect labeling. Consumers with questions should follow up with their healthcare provider or surgeon.
The recalled product
- Product
- Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 7L 16MM, VE Model/Catalog Number: 341-16-707
- Manufacturer
- Encore Medical, LP
- Hazard
- Affected units
- 14
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Code: Lot: 151T1055A GTIN: 00888912167147
Distribution
Part of a larger recall action
This product is one of 3 recalled by Encore Medical, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Encore Medical, LP
See all →- ModerateEMPOWR 3D Knee surgical device recalled due to packaging discrepancy
FDA (Devices) · 2026-07-15
- ModerateEMPOWR 3D KNEE insertion instruments recalled for incorrect product size packaging
FDA (Devices) · 2026-07-15
- HighShoulder prosthesis humeral socket inserts recalled over incorrect implant labeling
FDA (Devices) · 2026-03-04
- SevereReverse Shoulder Prosthesis Implants Recalled Over Incorrect Labeling
FDA (Devices) · 2026-03-04
- HighAcetabular liners recalled over packages containing the wrong component
FDA (Devices) · 2026-02-11
Same hazard · mis labeling
See all →- ModerateAllies Group Recalls Subpotent SPF 50 Sunscreen Gel Sachets
FDA (Drugs) · 2026-09-09
- SevereFayus Inc. Recalls OLA-OLA Pounded Yam for Undeclared Milk
FDA (Food) · 2026-09-09
- LowB Braun Recalls Discofix Stopcock Sets Due to Incorrect Expiration Date
FDA (Devices) · 2026-09-09
- ModerateWonton Skin Recalled for Undeclared Red Dye
FDA (Food) · 2026-09-09
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-09