# FDA recall Z-2133-2020

> **Smith & Nephew, Inc.** · Class II · device recall initiated 2020-01-28.

## Product

JOURNEY II UNI RESECTION PREP TRIAL, RIGHT MEDIAL/ LEFT LATERAL - Product Usage: The JOURNEY II Uni Resection Prep Trial is a reusable surgical instrument used during range of motion trialing to assess joint tension and component alignment during surgery. The provisional moveable spikes (spike rail) aids in provisional fixation of the trial.  SIZE 1, CATALOG NUMBER: REF 74035831  SIZE 2, CATALOG NUMBER: REF 74035832  SIZE 3, CATALOG NUMBER: REF 74035833  SIZE 4, CATALOG NUMBER: REF 74035834  SIZE 5, CATALOG NUMBER: REF 74035835  SIZE 6, CATALOG NUMBER: REF 74035836  SIZE 7, CATALOG NUMBER: REF 74035837  SIZE 8, CATALOG NUMBER: REF 74035838  SIZE 9, CATALOG NUMBER: REF 74035839  SIZE 10, CATALOG NUMBER: REF 74035840

## Reason for recall

The spike rail was manufactured with an oversized thru-hole which could potentially cause the dowel pin to fall out and the device to disassemble.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-2133-2020
- **Recalling firm:** Smith & Nephew, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-01-28
- **Report date:** 2020-06-03
- **Termination date:** 2023-12-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Memphis, TN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2133-2020

## Citation

> AI Analytics. FDA recall Z-2133-2020. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/Z-2133-2020. Source: US FDA. Licensed CC0.

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