# FDA recall Z-0277-2023

> **OrthoPediatrics Corp** · Class II · device recall initiated 2022-09-12.

## Product

Orthex Large Bone Shoulder Bolt, model no. AS-17

## Reason for recall

Bolt breakage on the head or threaded portion, which may cause loss of strut continuity with frame. This may cause loss of deformity correction and/or disruption of bone regeneration.

## Distribution

Domestic distribution to  Foreign distribution to

## Key facts

- **Recall number:** Z-0277-2023
- **Recalling firm:** OrthoPediatrics Corp
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-09-12
- **Report date:** 2023-02-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Warsaw, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0277-2023

## Citation

> AI Analytics. FDA recall Z-0277-2023. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-0277-2023. Source: US FDA. Licensed CC0.

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