Recall Z-2438-2015 ยท ISW Assembly, Knee/Shank/Ankle/Foot, External
Otto Bock Healthcare Product
Otto Bock Healthcare Products GmbH Genium X3 Model Number: 3B5-2, Manufacturer Otto Bock Healthcare Products GmbH. Intended to be used solely for lower limb prosthetic fittings.
| Date | Aug 21, 2015 (initiated Aug 12, 2015) |
| Status | Terminated |
| Reason | Otto Bock Healthcare Products GmbH is recalling the new Genium X3 knee joint prosthesis due to issues with the resistance-control of the hydraulics, which may fail under conditions. |
| Root cause | Process control |
| Action | The consignee was notified via e-mail and telephone on 12 August 2015. The affected product was identified, as well as the reason for the recall. The firm will replace the affected device with a new one. A return authorization and label will be provided for the recalled product to be returned as soon as possible. |
| Quantity | 1 |
| Distribution | Distributed to the state OH. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.