Recall Z-0388-06 ยท ISH Component, External, Limb, Ankle/Foot
Ossur
Elation, Class I Medical Device Prosthetic product, Component, External, Limb, Ankle/Foot Parts Numbers: ELP0023L/R-ELP0026L/R, ELP0023RBR, ELP0024RBR &, ELP0028RBR.
| Date | Jan 12, 2006 (initiated Oct 21, 2005) |
| Status | Terminated |
| Reason | After one year devices assembled with a new type of O-rings could exhibit enough wear to allow a gradual oil leak which would increase play in the ankle sub-assembly of the foot. |
| Root cause | Other |
| Action | Telephone communication followed by notification letter mailed to end users (patients) and prosthetics workshops. A pre-paid package to return faulty components to Ossur included with mailed letters. New replacement feet will be shipped to customers. |
| Quantity | 48 (23 in US) |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.