Recall Z-0131-2016 ยท PHX Shoulder Prosthesis, Reverse Configuration
Encore Medical, Lp
AltiVate Humeral Socket Shell Trial, Part Number 804-06-052 The glenoid baseplate is intended for cementless application with addition of screws for fixation. The humeral stem is intended for cemented or cementless use. This device may also be indicated in the salvage of previously failed surgical attempts. Shoulder reconstructive surgery should be reserved for patients who have failed non-operat
| Date | Oct 16, 2015 (initiated Sep 15, 2015) |
| Status | Terminated |
| Reason | Difficulty assembling the shell trial to the broach and the retaining ring disassembled from the screw. |
| Root cause | Device Design |
| Action | The firm, DJO Global, sent an "URGENT FIELD SAFETY NOTICE" letter dated 9/16/15 to affected consignees/customers. The letter described the product, problem, and actions to be taken. The consignees/customers were instructed quarantine the device, pass the notice on to all who need to be aware within your organization, contact customer service to place a replacement order and receive an RMA number; and to complete a response form and return the recalled device for a replacement. If you have any questions, please call (512) 834-6302 or by email at desiree.hubby@djoglobal.com. |
| Quantity | 20 units |
| Distribution | US Distribution to states of: PA, FL, ID, and CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141990 | ENCORE HUMERAL SHOULDER STEM Encore Medical L.P., Nov 7, 2014 |