Recall Z-1977-2025— Orthofix Srl

Name: FDA recall Z-1977-2025
Creator: U.S. Food and Drug Administration
Published: 2024-09-24

Class II · Ongoing

Class II FDA medical device recall by Orthofix Srl, initiated 2024-09-24. It names one FDA 510(k) clearance: K233867. Product: REF: 99-709245, Fitbone Trochanteric Nail L245mm, D9mm, Sterile. Reason: Retrospective; Their is the potential that implantable intramedullary lengthening nails may bend at the distal tail during insertion resulting in having to be replaced..

Recalling firm: Orthofix Srl
Classification: Class II
Status: Ongoing
Initiated: 2024-09-24
Firm location: Bussolengo, N/A, Italy

510(k) clearances named in this recall

1 on FDA's record

K233867 — Fitbone TrochantericOrthofix Srl·cleared 2024-06-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.