# FDA recall Z-2333-2020

> **Smith & Nephew, Inc.** · Class II · device recall initiated 2020-04-22.

## Product

smith&nephew R3 THREE HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes:  Size	REF/product number  40MM	71335540  42MM	71335542  44MM	71335544  46MM	71335546  48MM	71335548  50MM	71335550  52MM	71335552  54MM	71335554  56MM	71335556  58MM	71335558  60MM	71335560    Orthopedic implant component.

## Reason for recall

A manufacturing error resulted in out of specification R3 Acetabular Shells

## Distribution

Worldwide

## Key facts

- **Recall number:** Z-2333-2020
- **Recalling firm:** Smith & Nephew, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2020-04-22
- **Report date:** 2020-06-17

- **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-2333-2020

## Citation

> AI Analytics. FDA recall Z-2333-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2333-2020. Source: US FDA. Licensed CC0.

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