Orthofix US XCaliber Ankle Complete Kit, Sterile, 99-91647.… recallZ-1435-2010 · Orthofix Srl · initiated Feb 22, 2010
Terminated All recalls posted in April 2010
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Orthofix Srl or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
During standard quality controls, firm identified a potential for breakage of the XCaliber clamp when locking the cam.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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.
Recall details
- Recall number
- Z-1435-2010
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Feb 22, 2010
- Posted by the FDA
- Apr 28, 2010
- Recalling firm
- Orthofix Srl
- Quantity
- 25
- Product code
- JDW
- FDA submissions
- K955848
- Distribution
- Nationwide Distribution -- TX, ND, NY, FL and CA.
Product 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.
Code information (models, lots, serial numbers)
Lot Numbers: IT956155 and IT967331
Other devices under the same FDA submission
17 devices cleared under K955848 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- ORTHOFIX MODULSYSTEM 1Orthofix Srl · Pin, Fixation, Threaded1 recall2 reports
- ORTHOFIX MODULSYSTEM 1Orthofix Srl · Pin, Fixation, Threaded1 recall0 reports
- ORTHOFIX MODULSYSTEM 1Orthofix Srl · Pin, Fixation, Threaded1 recall0 reports
- ORTHOFIX MODULSYSTEM 1Orthofix Srl · Pin, Fixation, Threaded1 recall0 reports
- PREFIX FIXATOR 1Orthofix Srl · Pin, Fixation, Threaded7 reports
- PREFIX FIXATOR 1Orthofix Srl · Pin, Fixation, Threaded3 reports
- ORTHOFIX MODULSYSTEM 1Orthofix Srl · Pin, Fixation, Threaded1 report
- ORTHOFIX MODULSYSTEM 1Orthofix Srl · Pin, Fixation, Threaded1 report
- ORTHOFIX MODULSYSTEM 1Orthofix Srl · Pin, Fixation, Threaded1 report
- ORTHOFIX MODULSYSTEM 1Orthofix Srl · Pin, Fixation, Threaded1 report
- ORTHOFIX MODULSYSTEM 1Orthofix Srl · Pin, Fixation, Threaded1 report
- ORTHOFIX MODULSYSTEM 1Orthofix Srl · Pin, Fixation, Threaded1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 55182).
- Z-1434-2010 · TerminatedOrthofix US XCaliber Meta-Diaphyseal Complete Kit, Sterile. 99-91600, manufactured by Orthofix SRL, Via delle Nazioni, 9, 27012 Bussolengo (VR) Italy. Intended for use in the trea…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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