Recall Z-2469-2018 ยท HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Fx Solutions
Fx SOLUTIONS OFFSET HEAD CoCr 50x20, REF 106-5000 Product Usage: Device is designed to produce and deliver proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radi
| Date | Jun 4, 2018 |
| Status | Terminated |
| Reason | Breach in the external blister of certain lots of Humelock Offset Head 50 X 20 and Centered Head 50 X 19. |
| Root cause | Package design/selection |
| Action | The firm initiated the recall by email on 06/04/2018 in France, on 06/05/2018, to distributors in the US and elsewhere. The distributor (US Agent) sent the notice on to the division agents who store the product. The firm requested return of the units. |
| Quantity | 145 units |
| Distribution | Worldwide Distribution - US Nationwide and the countries of: France, Argentina, South Africa, Spain, Israel, Germany, Lebanon, Italy, Chile, Belgium, Greece, Mexico, Poland, Hong Kong, Switzerland |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111097 | HUMELOCK CEMENTED SHOULDER PROSTHESIS Fx Solutions, Nov 9, 2011 |