Home / Recalls / Orthofix Srl / Z-1977-2025

Z-1977-2025 Class II Ongoing

Recalled by Orthofix Srl — Bussolengo, N/A

Recall Details

Product Type
Devices
Report Date
June 25, 2025
Initiation Date
September 24, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2 units

Product Description

REF: 99-709245, Fitbone Trochanteric Nail L245mm, D9mm, Sterile

Reason for Recall

Retrospective; Their is the potential that implantable intramedullary lengthening nails may bend at the distal tail during insertion resulting in having to be replaced.

Distribution Pattern

US: Unknown, OUS: Unknown

Code Information

Lot # B4771336 and B4771337, UDI: 18059015373653

Other recalls by Orthofix Srl

  • Z-0391-2020 Class II — ORTHOFIX Catalogue Number: ref: 99-92502, PREFIX II DIAPHYSEAL COMPLETE KIT ST (September 27, 2018)
  • Z-0397-2020 Class II — ORTHOFIX Catalogue Number: ref: 99-93502, LOWER LIMB DIAPHYSEAL STERILE KIT, R (September 27, 2018)
  • Z-0401-2020 Class II — ORTHOFIX Catalogue Number: ref: 99-93503US, ANKLE TRANSFIX PIN STERILE KIT, UD (September 27, 2018)
  • Z-0393-2020 Class II — ORTHOFIX Catalogue Number: ref: 99-92504, PREFIX II ANKLE COMPLETE KIT STERILE, (September 27, 2018)
  • Z-0398-2020 Class II — ORTHOFIX Catalogue Number: ref: 99-93502JP, LOWER LIMB DIAPHYSEAL STERILE KIT (S (September 27, 2018)
  • Z-0381-2020 Class II — ORTHOFIX Catalogue Number: ref 1-1100201,DRILL BIT Diameter .4,8 MM L.240 MM TIN (September 27, 2018)
  • Z-0382-2020 Class II — ORTHOFIX Catalogue Number: ref 1-1100301,DRILL BIT Diameter 3.2 MM L. 200 MM TIN (September 27, 2018)
  • Z-0400-2020 Class II — ORTHOFIX Catalogue Number: ref:99-93503 , ANKLE STERILE KIT, UDI: (01)1803350 (September 27, 2018)
  • Z-0373-2020 Class II — ORTHOFIX Catalogue Number: ref 11007, drill bit diameter 4.8 MM LENGTH 280 MM, R (September 27, 2018)
  • Z-0402-2020 Class II — ORTHOFIX Catalogue Number: ref: 99-93504, ELBOW STERILE KIT, UDI: (01)18054242 (September 27, 2018)