FDA Medical Device Recalls (openFDA)
Orthofix Srl: Orthofix 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 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 number
- Z-1434-2010
- Recalling firm
- Orthofix Srl
- Product
- Orthofix 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 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.
- Status
- Terminated
- Initiated
- 2010-02-22
- Posted
- 2010-04-28
- Terminated
- 2010-05-05
- 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
- 9
- Distribution
- Nationwide Distribution -- TX, ND, NY, FL and CA.
- Lot, serial or model codes
- Lot Numbers: IT965408
- 510(k) numbers
- ["K955848"]
- PMA numbers
- not on file
- Product code
- JDW
- Firm FEI
- 3002807827
- Firm city
- Bussolengo Verona
- Firm state
- not on file
- Firm country
- Italy
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28