# FDA recall Z-1672-2023

> **Smith & Nephew, Inc.** · Class II · device recall initiated 2023-05-02.

## Product

Smith&Nephew ENGAGE Cementless Partial Knee System, Coated Tibial Tray, Part Numbers:  a)	REF 1-10012-100, SIZE 1-LEFT MEDIAL;   b)	REF 1-10012-150, SIZE 1-RIGHT MEDIAL;   c)	REF 1-10012-200, SIZE 2-LEFT MEDIAL;   d)	REF 1-10012-250, SIZE 2-RIGHT MEDIAL;   e)	REF 1-10012-300, SIZE 3-LEFT MEDIAL;   f)	REF 1-10012-350, SIZE 3-RIGHT MEDIAL;  g)	REF 1-10012-400, SIZE 4-LEFT MEDIAL;   h)	REF 1-10012-450, SIZE 4-RIGHT MEDIAL;  i)	REF 1-10012-500, SIZE 5-LEFT MEDIAL;    j)	REF 1-10012-550, SIZE 5-RIGHT MEDIAL;   k)	REF 1-10012-600, SIZE 6-LEFT MEDIAL;   l)	REF 1-10012-650, SIZE 6-RIGHT MEDIAL;   Unicondylar knee prothesis

## Reason for recall

Recent complaint data indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement registries. The data identifies a potential signal that the performance is an outlier versus the state of the art with respect to the risk for revision.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-1672-2023
- **Recalling firm:** Smith & Nephew, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-05-02
- **Report date:** 2023-06-07

- **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-1672-2023

## Citation

> AI Analytics. FDA recall Z-1672-2023. Retrieved 2026-07-25 from https://api.ai-analytics.org/recall/Z-1672-2023. Source: US FDA. Licensed CC0.

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