Encore Medical Recalls EMPOWR Acetabular Cups Due to Machining Defect
Encore Medical is recalling 12 EMPOWR Acetabular Cups due to a manufacturing defect that prevents proper seating. The affected cups were distributed nationwide in specific U.S. states.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect in a medical device that could lead to improper seating, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Encore Medical, LP is recalling 12 units of the EMPOWR Acetabular Cup, Cluster Hole, 54G (REF 940-02-54G, Lot 801Z1036). The recall is due to incomplete machining that left a small peg remnant on the top of the dome. This protrusion extends above the surrounding porous coating, causing the cup not to seat properly during total hip arthroplasty.
The affected products were distributed nationwide, including in California, Minnesota, Mississippi, New York, South Carolina, Tennessee, and Virginia. The agency has classified this as a Class II recall.
Healthcare providers and patients should contact Encore Medical, LP for instructions on how to return the affected devices. The source text does not report any illnesses or injuries associated with this defect.
The recalled product
- Product
- EMPOWR Acetabular System *** EMPOWR Acetabular Cup, Cluster Hole, 54G *** Size 54G 54 mm Dia./Cluster Hole Alpha Code G Liner P2 Porous Coated REF 940-02-54G - Product Usage: are intended for treatment of patients who are candidates for total hip arthroplasty per the indication
- Manufacturer
- Encore Medical, LP
- Affected units
- 12
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)
- Model Number: 940-02-54G Lot Number: 801Z1036
Distribution
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
- SevereReverse Shoulder Prosthesis Implants Recalled Over Incorrect Labeling
FDA (Devices) · 2026-03-04
- HighShoulder prosthesis humeral socket inserts recalled over incorrect implant labeling
FDA (Devices) · 2026-03-04
- SevereKnee and Humeral Socket Implants Recalled for Incorrect Labeling
FDA (Devices) · 2026-03-04
Same hazard · manufacturing defect
See all →- HighBeak & Skiff Alcohol Antiseptic Sanitizer recalled for acetaldehyde contamination
FDA (Drugs) · 2026-09-02
- HighSun Pharmaceutical Recalls Carbamazepine Tablets Due to Manufacturing Deviations
FDA (Drugs) · 2026-08-26
- HighKnee Prosthesis Trial Recall for Manufacturing Defect
FDA (Devices) · 2026-08-12
- HighU2 Total Knee System Femoral Valgus Adaptor Recall
FDA (Devices) · 2026-08-12
- HighUSTAR II Knee System Hinge Box Trial Recall
FDA (Devices) · 2026-08-12