# FDA recall Z-1977-2025

> **Orthofix Srl** · Class II · device recall initiated 2024-09-24.

## 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

- **Recall number:** Z-1977-2025
- **Recalling firm:** Orthofix Srl
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-09-24
- **Report date:** 2025-06-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bussolengo, N/A, Italy

## Primary source

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

## Citation

> AI Analytics. FDA recall Z-1977-2025. Retrieved 2026-08-02 from https://api.ai-analytics.org/recall/Z-1977-2025. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*