EMPOWR Acetabular System recall
EMPOWR Acetabular System, Non-Sterile, Model Numbers 803-15-023 803-15-026 803-15-027 803-15-028 803-15-029 803-15-030 Product Usage: The EMPOWR…
Why was EMPOWR Acetabular System recalled?
The firm received complaints that the EMPOWR Acetabular Impactor Balls were fracturing/cracking during impaction which could cause debris to migrate or be left in the joint space.
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?
All lots
- Product
- EMPOWR Acetabular System, Non-Sterile, Model Numbers 803-15-023 803-15-026 803-15-027 803-15-028 803-15-029 803-15-030 Product Usage: The EMPOWR…
- Recalling firm
- Encore Medical, LP
- Quantity
- 86 units
- Distribution
- US Nationwide distribution including in the states of MN, VA, IL, IN, SC, N, TX, CA.
- Recall date
- May 20, 2020
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)