Recall Z-0135-2021 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Encore Medical, LP
EMPOWR Acetabular System *** EMPOWR Acetabular Cup, Cluster Hole, 54G *** Size 54G 54 mm Dia./Cluster Hole Alpha Code G Liner P2 Porous Coated REF 940-02-54G - Product Usage: are intended for treatment of patients who are candidates for total hip arthroplasty per the indications for use.
| Date | Sep 9, 2020 |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Employee error |
| Action | On 09/11/2020, the firm sent out an email containing an "URGENT FIELD SAFETY NOTICE" to it Surgical/Sales Agents informing them that a product complaint was received stating that a surgeon had issues with implanting the device and stated that "too tight even after reaming line-to-line" and that the affected device did not seat properly. The Recalling Firm was notifying its agents to immediately return all unused affected devices and pointed out that the risks associated with this issue include the following: -Lack of cup fixation -Device loosening -Fracture -Pain -Delay in Surgery -Revision S |
| Quantity | 12 cups |
| Distribution | U.S. Nationwide distribution including in the states of CA, MN, MS, NY, SC, TN and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K190057 | DJO Acetabular System Encore Medical L.P., Jun 7, 2019 |