Recall Z-1241-2018 ยท PHX Shoulder Prosthesis, Reverse Configuration
Encore Medical, Lp
AltiVate Reverse INSTRUMENTATION, HUMERAL SOCKET SHELL TRIAL, STANDARD, REF 804-06-152, Qty: 01, Encore Medical, LP Orthopedic surgical instrument. Product Usage: The humeral socket shell trial is used to replicate/trial the shell geometry of the AltiVate Reverse Standard Shell Humeral Stem implants. It assembles to the humeral broaches by a screw in order to replicate/trial the entire humeral s
| Date | Mar 5, 2018 (initiated Jan 30, 2018) |
| Status | Terminated |
| Reason | Broken or missing screws and retaining clips. This may be due to screw tolerance and material strength of the trial. |
| Root cause | Device Design |
| Action | The firm disseminated their field safety notices on 01/30/2018 by email. The letter identified the affected product, problem and actions to be taken. The notices requested the trails be returned for replacement. |
| Quantity | 387 units |
| Distribution | US Nationwide Distribution |
| 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 |