# FDA recall Z-0933-2021

> **Smith & Nephew, Inc.** · Class II · device recall initiated 2020-12-18.

## Product

VERSABOND AB 40 GRAMS FORMULATION 2, antibiotic infused bone cement, Product Number: 71271440 - Product Usage: VERSABOND is a medium viscosity bone cement which can be used for hip, knee, and shoulder implant fixation. VERSABOND AB includes the antibiotic- gentamycin.

## Reason for recall

Potential heat and humidity exposure. The affected lot contained an atypical sandy, flaky or grainy consistency when mixing.

## Distribution

Worldwide distribution - US Nationwide distribution in the state of OH and the countries of Dubai, Canada, Korea, Chile, Puerto Rico, Panama, and Costa Rica.

## Key facts

- **Recall number:** Z-0933-2021
- **Recalling firm:** Smith & Nephew, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-12-18
- **Report date:** 2021-02-10
- **Termination date:** 2023-05-01

- **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-0933-2021

## Citation

> AI Analytics. FDA recall Z-0933-2021. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-0933-2021. Source: US FDA. Licensed CC0.

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