Reason/Issue |
This action is being initiated because the last hole on the VEPTR Caudal Rib Supports, subject to this recall, may be partially formed. Fully lengthening the construct to the partially formed last hole may result in mechanical failure of the construct due to extension bar breakage, which could require unplanned surgical intervention to exchange components. In addition to the risks inherent to re-operation, potential effects on the patient could also include pain, loss of deformity correction, and/or soft tissue/visceral injury. |