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Open, Classified

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

FDA Recall Z-1977-2025 · Posted 2025-06-13

Recalling FirmOrthofix Srl
Recall StatusOpen, Classified
Product CodeHSB
Date Initiated2024-09-24
Product Quantity2 units

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.

Firm Action

No official notification was sent to customers. Orthofix representative was present during the first clinical case and both devices were returned as part of the complaint investigation process.

Root Cause

Use error

Distribution Pattern

US: Unknown, OUS: Unknown

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K233867Fitbone TrochantericOrthofix Srl · 2024-06-18

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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