Recall Z-0826-2019 ยท ISY Joint, Knee, External Limb Component
Ottobock Orthopedic Industrie
21Y14 PushValve Product Usage: The PushValves/ MagValves is intended exclusively for the prosthetic fitting of lower limb amputees. The valve is a threadless one-way valve. It is used to evacuate air from the prosthetic socket.
| Date | Jan 10, 2019 |
| Status | Terminated |
| Reason | Some of the installed valve-inserts have a diameter smaller than the specification. |
| Root cause | Process control |
| Action | The firm initiated the recall by email on 01/10/2019 and followed with a letter on 01/11/2019. The letter identified the affected product, problem, actions to be taken and that a second letter with the replacement unit was forthcoming. |
| Quantity | 538 units |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.