FDA Recall
Terminated
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.
Recall: Z-1435-2010
·
Initiated February 22, 2010
Recall
- Recall Number
- Z-1435-2010
- Event Number
- 55182
- Firm
- Orthofix Srl Via Delle Nazioni 9 Bussolengo (Verona) Italy
- FEI Number
- 3002807827
- Product Code
- JDW
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- February 22, 2010
- Posted
- April 28, 2010
- Terminated
- May 5, 2010
Description
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.
Reason
During standard quality controls, firm identified a potential for breakage of the XCaliber clamp when locking the cam.
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.
Distribution
Nationwide Distribution -- TX, ND, NY, FL and CA.
Quantity
25