Z-1929-2020 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- May 20, 2020
- Initiation Date
- October 22, 2019
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 86 units
Product Description
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 Acetabular Impactor Balls is intended for use in joint replacement in patients suffering from disability due to noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of the natural femoral head; rheumatoid arthritis, correction of functional deformity, femoral fracture, and in the salvage of previously failed surgical attempts.
Reason for Recall
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.
Distribution Pattern
US Nationwide distribution including in the states of MN, VA, IL, IN, SC, N, TX, CA.
Code Information
All lots