Encore Medical Recalls EMPOWR 3D KNEE Implants Due to Incorrect Labeling
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Encore Medical, LP has issued a voluntary recall for EMPOWR 3D KNEE implants distributed across 17 states due to labeling errors on the packaging.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 6, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, MedicalDevices.
What Happened
Encore Medical, LP has initiated a voluntary recall of specific EMPOWR 3D KNEE implants. The recall was triggered because the knee and humeral socket implants were found to contain incorrect labeling. This labeling error could lead to confusion regarding the product's specifications during surgical procedures.
Which Products Are Affected
The recall affects 14 implants with the following specifications:
- Brand Name: EMPOWR 3D KNEE
- Product Name: EMPOWR 3D KNEE INS, 7L 16MM, VE
- Model/Catalog Number: 341-16-707
- Lot Code: 151T1055A
- GTIN: 00888912167147
- Recall Number: Z-1459-2026
Distribution was limited to the following U.S. states: VA, TN, IL, IN, MI, CO, WY, MT, RI, MA, NJ, PA, MO, OK, LA, FL, and CA.
What You Should Do
Healthcare providers and facilities should immediately check their inventory for the affected lot code (151T1055A). The firm initiated the recall notification via letter on January 15, 2026. If you have these products in your possession, follow the instructions provided in the notification letter regarding the return or replacement of the units. For further inquiries, contact Encore Medical, LP at their Austin, Texas location.
Why This Matters
Correct labeling is essential for medical devices to ensure that surgeons select the appropriate components for patients. Incorrect labeling on implants can lead to surgical complications or the use of improper medical hardware.
Source
This information is sourced from the FDA (Recall Event ID: 98340).
Original source: FDA Official Notice ↗
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