# FDA recall Z-1029-2019

> **Smith & Nephew, Inc.** · Class II · device recall initiated 2019-02-19.

## Product

smith&nephew SMF(TM) HIGH OFFSET STIKTITE(TM) COATED STEM 12/14 TAPER -1H SIZE, STEM,  REF 713552511

## Reason for recall

Complaints were received indicating that the outer label incorrectly identified the product as size "1" instead of "-1".  The product contained within the package is size "-1"

## Distribution

US:  CA, TN, NC, AR, IN, FL, MO, and, Canada, China, France, Germany, Great Britain, India, Italy, Japan, Mexico, Poland, South Korea, Spain

## Key facts

- **Recall number:** Z-1029-2019
- **Recalling firm:** Smith & Nephew, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-02-19
- **Report date:** 2019-03-27
- **Termination date:** 2021-05-21

- **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-1029-2019

## Citation

> AI Analytics. FDA recall Z-1029-2019. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-1029-2019. Source: US FDA. Licensed CC0.

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