Device recall

Z-1434-2010: Orthofix US XCaliber Meta-Diaphyseal Complete Kit, Sterile. 99-91600…

FDA device recall · Class II · Orthofix Srl

Key facts

Recall number (Z-number) Z-1434-2010
Recall event 55182
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…
Product code JDW
Recalling firm Orthofix Srl
Recall class Class II
Status Terminated
Termination date May 5, 2010
510(k) numbers K955848
FEI number 3002807827

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

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