FDA recall Z-1977-2025

Product

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

US: Unknown, OUS: Unknown

Key facts

Status

Ongoing

Initiation date

2024-09-24

Report date

2025-06-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bussolengo, N/A, Italy

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1977-2025