# FDA recall Z-1671-2023

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

## Product

Smith&Nephew ENGAGE Cementless Partial Knee System, Tibial Anchor Stem, Part Numbers:  a)  REF 1-10011-100 (SIZE 1-2), b)  REF 1-10011-200 (SIZE 3-4), c)  REF 1-10011-300 (SIZE 5-6); 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-1671-2023
- **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-1671-2023

## Citation

> AI Analytics. FDA recall Z-1671-2023. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1671-2023. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*