# FDA recall Z-2134-2018

> **Orthofix, Inc** · Class II · device recall initiated 2018-04-06.

## Product

T-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (003-B-01001);  b) Large (003-B-02001)

## Reason for recall

Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.

## Distribution

U.S Consignees: NJ, FL, PA, SC, LA, VA, MN, TX, GA, DC, NV, IN, CA, MI, IL, MD, NC, OH, OK,

## Key facts

- **Recall number:** Z-2134-2018
- **Recalling firm:** Orthofix, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-04-06
- **Report date:** 2018-06-13
- **Termination date:** 2021-06-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lewisville, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2134-2018

## Citation

> AI Analytics. FDA recall Z-2134-2018. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/Z-2134-2018. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*