# FDA recall Z-2122-2018

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

## Product

Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) D 2.7MM X 8MM (002-E-27008),  b) D 2.7MM X 10MM (002-E-27010);  c) D 2.7MM X 12MM (002-E-27012);  d) D 2.7MM X 14MM (002-E-27014);  e) D 2.7MM X 16MM (002-E-27016);  f) D 2.7MM X 18MM (002-E-27018);  g) D 2.7MM X 20MM (002-E-27020);  h) D 2.7MM X 22MM (002-E-27022);  i) D 2.7MM X 24MM (002-E-27024);  j) D 2.7MM X 26MM (002-E-27026);  k) D 2.7MM X 28MM (002-E-27028);  l) D 2.7MM X 30MM (002-E-27030);  m) D 2.7MM X 32MM (002-E-27032);  n) D 2.7MM X 34MM (002-E-27034);  o) D 2.7MM X 36MM (002-E-27036);  p) D 2.7MM X 38MM (002-E-27038);  q) D 2.7MM X 40MM (002-E-27040)

## 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-2122-2018
- **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-2122-2018

## Citation

> AI Analytics. FDA recall Z-2122-2018. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-2122-2018. Source: US FDA. Licensed CC0.

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