Recall Z-0626-2016 ยท PHX Shoulder Prosthesis, Reverse Configuration
Encore Medical, Lp
AltiVate Reverse Humeral Broach, Size 10 Catalog number 804-06-040, Size 14 Catalog number 804-06-044, and Size 16 Catalog number 804-06-046. Orthopedic surgical instrument for use with Encore Shoulder prosthesis.
| Date | Jan 9, 2016 (initiated Dec 8, 2015) |
| Status | Terminated |
| Reason | The trial shell mating feature on the broach is undersized. |
| Root cause | Nonconforming Material/Component |
| Action | The recalling firm notified customers of the recall via letter on 12/8/15. |
| Quantity | 23 units |
| Distribution | Throughout the US to the states: FL, PA, ID, CA, OH, AZ, TN, NV, WA, MS, GA, MA, KS, TX |
| 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 |