# FDA recall Z-2742-2020

> **OrthoPediatrics Corp** · Class II · device recall initiated 2020-07-06.

## Product

Orthopedics 6.0MM ROD, COCR, SINGLE HEX, 500MM LENGTH-The RESPONSE" 5.5/6.0 Spine System is intended for immobilization and  stabilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease  Model Number: 00-1300-6053

## Reason for recall

Product may have incorrect laser etched alignment lines,  the non-conforming laser etch may have compromised strength, lead to unintended fracture of the device

## Distribution

US Nationwide distribution including in the states of Al, CA, FL, GA, KY, MI, MO, NC, NY, OH, TX.

## Key facts

- **Recall number:** Z-2742-2020
- **Recalling firm:** OrthoPediatrics Corp
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2020-07-06
- **Report date:** 2020-08-05

- **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-2742-2020

## Citation

> AI Analytics. FDA recall Z-2742-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2742-2020. Source: US FDA. Licensed CC0.

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