---
title: "Orthex Large Bone Shoulder Bolt, model no. AS-17 — FDA record Z-0277-2023 | Is It on Recall"
description: "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 disruptio"
url: https://isitonrecall.com/recall/fda-device-z-0277-2023-orthex-large-bone-shoulder-bolt-model-no-as-17/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# Orthex Large Bone Shoulder Bolt, model no. AS-17 — FDA record Z-0277-2023

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Sep 12, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: Orthex Large Bone Shoulder Bolt, model no. AS-17
- **Reason**: 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.
- **Classification**: Class II
- **Recalling firm**: OrthoPediatrics Corp
- **Quantity**: 1354 (594 US)
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-0277-2023

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0277-2023%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | UDI-DI: 00841132143155 Lots: 921052140-E 922000760-E 922023360-E 922023370-E 922038571-E 922038581-E 922038591-E |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

Domestic distribution to Foreign distribution to

No US distribution state could be established from this record. Check the official notice.

## Dates in the source

- **Report date**: Feb 22, 2023
- **Recall initiation date**: Sep 12, 2022
- **Center classification date**: Feb 10, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0277-2023%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [OrthoPediatrics Corp records](https://isitonrecall.com/brand/orthopediatrics-corp/)