Device 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 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.
Z-1929-2020
Product summary
- Event
- Event 85376
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 86 units
- Official record key
device-enforcement:Z-1929-2020
Official wording
Reason: 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.
Code information: All lots
Distribution pattern: US Nationwide distribution including in the states of MN, VA, IL, IN, SC, N, TX, CA.
Derived failure modes
-
Unknown
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.