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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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…
- 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
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