# FDA recall Z-1670-2023

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

## Product

Smith&Nephew ENGAGE Cementless Partial Knee System, Porous Femoral components, Part Numbers:    a)  REF 1-10003-100 (SIZE 1 Right Medial);   b)	REF 1-10003-110 (SIZE 1 Left Medial);   c)	REF 1-10003-200 (SIZE 2-Right Medial);   d)	REF 1-10003-210 (SIZE 2-Left Medial);   e)	REF 1-10003-300 (SIZE 3- Right Medial);   f)	REF 1-10003-310 (SIZE 3- Left Medial);   g)	REF 1-10003-400 (SIZE 4- Right Medial);   h)	REF 1-10003-410 (SIZE 4- Left Medial);   i)	REF 1-10003-500 (SIZE 5- Right Medial);   j)	REF 1-10003-510 (SIZE 5- Left Medial);   k)	REF 1-10003-600 (SIZE 6- Right Medial);   l)	REF 1-10003-610 (SIZE 6- Left Medial);   m)	REF 1-10003-700 (SIZE 7- Right Medial);   n)	REF 1-10003-710 (SIZE 7- Left Medial);   o)  REF 1-10003-800, (SIZE 8 - Right Medial);   p)  REF 1-10003-810, (SIZE 8 - Left 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-1670-2023
- **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-1670-2023

## Citation

> AI Analytics. FDA recall Z-1670-2023. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/Z-1670-2023. Source: US FDA. Licensed CC0.

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