Medical device recalls Moderate risk

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

Recall date
September 24, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1977-2025
FDA classification
Class II
Brand / firm
Orthofix Srl
Sold / distributed
US: Unknown, OUS: Unknown

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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