# FDA recall Z-1678-2022

> **OrthoPediatrics Corp** · Class II · device recall initiated 2022-06-29.

## Product

Orthex External Fixation  Wire Sharp Bayonet 1.8 x 400 mm  Model:  K400-18BN

## Reason for recall

Manufacturing variance near transition of tip is increasing the likelihood the wire tip may fracture. The fractured tip may be retained in the patient. Retrieval attempts may be made which could result in a delay of surgery and potentially damage soft tissue and increase healing time

## Distribution

US Nationwide Distribution: AZ, AL, CA, FL, FL, MD, MO, NC, NY, TX   Foreign: Australia

## Key facts

- **Recall number:** Z-1678-2022
- **Recalling firm:** OrthoPediatrics Corp
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-06-29
- **Report date:** 2022-09-14

- **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-1678-2022

## Citation

> AI Analytics. FDA recall Z-1678-2022. Retrieved 2026-07-18 from https://api.ai-analytics.org/recall/Z-1678-2022. Source: US FDA. Licensed CC0.

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