Recall Z-0625-2024 ยท PHX Shoulder Prosthesis, Reverse Configuration
Encore Medical, LP
Reverse Shoulder System e+, REF 509-01-032, RSP Humeral Socket Insert, Sz. 32mm, Semi-Constrained, Sterile H2o2, CE 2797
| Date | Jan 2, 2024 (initiated Oct 5, 2023) |
| Status | Completed |
| Reason | Mislabeling |
| Root cause | Packaging process control |
| Action | On October 5, 2022, DJO Global (Enovis company) issued a "Urgent Medical Device Recall" Notification via E-Mail. DJO asked consignees to take the following actions: 1. This notice needs to be passed on to all those within your organization or to any organization where the potentially affected product has been transferred. 2. Review your stock for the affected products and lot numbers for the items to be returned. 3. Complete acknowledgement and response form and contact Customer Service at 1-800-456-8696 to place a replacement order and receive an RMA number. You will be provided with a ship |
| Quantity | 17 units |
| Distribution | US Nationwide distribution in the states of VA, TN, MN, IN, RI, ME, TX, LA, AL, FL, CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051075 | ENCORE REVERSE SHOULDER PROSTHESIS Encore Medical L.P., May 27, 2005 |