Orthofix Srl: Medical Device Recall in 2019 - (Recall #: Z-0388-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

ORTHOFIX Catalogue Number: ref: 99-91647, US XCALIBER ANKLE COMPLETE KIT, RX ONLY, UDI: (01)18032937167791

Product Classification:

Class II

Date Initiated: September 27, 2018

Date Posted: November 20, 2019

Recall Number: Z-0388-2020

Event ID: 84004

Reason for Recall:

As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance.

Status: Terminated

Product Quantity: N/A

Code Information:

Lot # B1201157, B1203789, B1226060

Distribution Pattern:

US: AZ, CA,FL,GA,HI,IA,IL,IN,KY,LA,MD,MI,MO,MS,NC,NY,OH,OK,OR,PA,SC,TN,TX,UT,VA,WA, WI, WV, Puerto Rico OUS: Kuwait, Australia, Saudi Arabia, United Arab Emirates, Ireland, Japan, Spain, Poland, Switzerland, Singapore, Peru, Brazil, Germany, Great Britain, France, Italy, Australia, South Africa, Belgium, Chile, The Netherlands, Lithuania, Sri Lanka, Denmark, Israel

Voluntary or Mandated:

Voluntary: Firm initiated