Recall Z-1929-2020 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Encore Medical, LP
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
| Date | Oct 22, 2019 |
| Status | Open, Classified |
| 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. |
| Root cause | Device Design |
| Action | The firm requested its agents to identify and return affected devices. |
| Quantity | 86 units |
| Distribution | US Nationwide distribution including in the states of MN, VA, IL, IN, SC, N, TX, CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K190057 | DJO Acetabular System Encore Medical L.P., Jun 7, 2019 |