# FDA recall Z-2120-2018

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

## Product

Locking Screw, D 2.0MM X 8MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label. Size (Part Number): a) D 2.0MM X 8MM (002-E-20008); b) D 2.0MM X 10MM (002-E-20010);   c) D 2.0MM X 12MM (002-E-20012);   d) D 2.0MM X 14MM (002-E-20014);   e) D 2.0MM X 16MM (002-E-20016);   f) D 2.0MM X 18MM (002-E-20018);   g) D 2.0MM X 20MM (002-E-20020);   h) D 2.0MM X 22MM (002-E-20022);   i) D 2.0MM X 24MM (002-E-20024);   j) D 2.0MM X 26MM (002-E-20026);   k) D 2.0MM X 28MM (002-E-20028);   l) D 2.0MM X 30MM (002-E-20030)

## 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-2120-2018
- **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-2120-2018

## Citation

> AI Analytics. FDA recall Z-2120-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2120-2018. Source: US FDA. Licensed CC0.

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