Recall Z-1435-2010 ยท JDW Pin, Fixation, Threaded
Orthofix Srl
Orthofix US XCaliber Ankle Complete Kit, Sterile, 99-91647. manufactured by Orthofix SRL, Via delle Nazioni, 9, 27012 Bussolengo (VR) Italy. Intended for use in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation and other bone conditions amenable to treatment by use of the external fixation modality.
| Date | Apr 28, 2010 (initiated Feb 22, 2010) |
| Status | Terminated |
| Reason | During standard quality controls, firm identified a potential for breakage of the XCaliber clamp when locking the cam. |
| Root cause | Nonconforming Material/Component |
| Action | Orthofix issued an "Urgent: Field Safety Notice" dated February 22, 2010. Consignees were informed of the affected product and instructed to cease use and to return the product to the firm. |
| Quantity | 25 |
| Distribution | Nationwide Distribution -- TX, ND, NY, FL and CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K955848 | ORTHOFIX MODULSYSTEM Orthofix, Inc., Mar 20, 1996 |