Recall Z-2261-2015 ยท ISY Joint, Knee, External Limb Component
Otto Bock Healthcare GmbH
Ottobock Pheon 3R62 Knee Joint The 3R62 Pheon is a polycentric prosthetic knee joint intended to be used solely for lower limb prosthetic fittings. It is available in several versions to allow attachment to other components based on the patient need and physiology.
| Date | Jul 24, 2015 (initiated Jul 16, 2015) |
| Status | Terminated |
| Reason | Otto Bock Healthcare GmbH is voluntarily recalling all 3R62 Pheon polycentric prosthetic knee joints distributed since February 2014 because the locking function may fail under certain conditions which may result in a fall. |
| Root cause | Component design/selection |
| Action | The firm, Ottobock, sent an "URGENT MEDICAL DEVICE RECALL 3R62 Pheon" letter dated 16 July 2015 to its customers. The letter described the product, problem, and actions to be taken. The customers instructed to read this notice in its entirety; examine your stock for 3R62 Pheon devices; quarantine 3R62 Pheon devices and prevent further distribution; contact Ottobock customer service at (800) 328-4058-option 1 or (512) 806-2000 -Option 1, to obtain a return authorization for those devices, and complete and return the MEDICAL DEVICE RECALL RETURN RESPONSE Acknowledgement and Receipt Form via |
| Quantity | 518 (439 US; 79 OUS) |
| Distribution | Worldwide Distribution: US (nationwide) and countries of: AU, BE, CN, CZ, IT, NL, and SK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.