# FDA recall Z-2124-2018

> **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 3.2MM X 10MM	(002-E-32010)  b) D 3.2MM X 12MM (002-E-32012)  c) D 3.2MM X 14MM (002-E-32014)  d) D 3.2MM X 16MM (002-E-32016)  e) D 3.2MM X 18MM (002-E-32018)  f) D 3.2MM X 20MM (002-E-32020)  g) D 3.2MM X 22MM (002-E-32022)  h) D 3.2MM X 24MM (002-E-32024)  i) D 3.2MM X 26MM (002-E-32026)  j) D 3.2MM X 28MM (002-E-32028)  k) D 3.2MM X 30MM (002-E-32030)  l) D 3.2MM X 32MM (002-E-32032)  m) D 3.2MM X 34MM (002-E-32034)  n) D 3.2MM X 36MM (002-E-32036)  o) D 3.2MM X 38MM (002-E-32038)  p) D 3.2MM X 40MM (002-E-32040)  q) D 3.2MM X 42MM (002-E-32042)  r) D 3.2MM X 44MM (002-E-32044)  s) D 3.2MM X 46MM (002-E-32046)  t) D 3.2MM X 48MM (002-E-32048)  u) D 3.2MM X 50MM (002-E-32050)

## 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-2124-2018
- **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-2124-2018

## Citation

> AI Analytics. FDA recall Z-2124-2018. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/Z-2124-2018. Source: US FDA. Licensed CC0.

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