# FDA recall Z-0218-2020

> **OrthoPediatrics Corp** · Class II · device recall initiated 2019-08-19.

## Product

Model No. 01-1501-0032 (Child Nail Attachment Bolt). Component of the Pediatric Nailing Platform. Product Usage: an orthopedic implant system commonly referred to as an intramedullary fixation rod (product code HSB). The attachment bolts are one component of the surgical instruments within the system.

## Reason for recall

Binding can occur between the attachment bolt and intramedullary nail, which may lead to delays in surgical procedures.

## Distribution

Worldwide distributions - US Nationwide distributions including states of AL, AZ, CA, CO, FL, GA, IA, IL, IN,   KY, MD, MI, NC, NY, OH, OK, TN, TX, UT, VA, WA, and WI. Country of Australia.

## Key facts

- **Recall number:** Z-0218-2020
- **Recalling firm:** OrthoPediatrics Corp
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-08-19
- **Report date:** 2019-11-06
- **Termination date:** 2020-04-30

- **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-0218-2020

## Citation

> AI Analytics. FDA recall Z-0218-2020. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0218-2020. Source: US FDA. Licensed CC0.

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