EMPOWR Acetabular System *** EMPOWR Acetabular Cup recall
EMPOWR Acetabular System *** EMPOWR Acetabular Cup, Cluster Hole, 54G *** Size 54G 54 mm Dia./Cluster Hole Alpha Code G Liner P2 Porous Coated REF…
Why was EMPOWR Acetabular System *** EMPOWR Acetabular Cup recalled?
Due to incomplete machining a small peg remnant on the top of the dome that protrudes above the surrounding porous coating causing the cup not to seat properly.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model Number: 940-02-54G Lot Number: 801Z1036
- 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…
- Recalling firm
- Encore Medical, LP
- Quantity
- 12 cups
- Distribution
- U.S. Nationwide distribution including in the states of CA, MN, MS, NY, SC, TN and VA.
- Recall date
- October 28, 2020
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)