# FDA recall Z-1673-2023

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

## Product

Smith&Nephew ENGAGE Cementless Partial Knee System, Coated Tibial Insert, Part Numbers:    a)	REF 1-10013-109, SIZE 1-LEFT MED, 9MM;   b)	REF 1-10013-110, SIZE 1-LEFT MED, 10MM;   c)	REF 1-10013-111, SIZE 1-LEFT MED, 11MM;   d)	REF 1-10013-113, SIZE 1-LEFT MED, 13MM;   e)	REF 1-10013-159, SIZE 1-RIGHT MED, 9MM;   f)	REF 1-10013-160, SIZE 1-RIGHT MED, 10MM;   g)	REF 1-10013-161, SIZE 1-RIGHT MED, 11MM;   h)	REF 1-10013-163, SIZE 1-RIGHT MED, 13MM;   i)	REF 1-10013-209, SIZE 2-LEFT MED, 9MM;   j)	REF 1-10013-210, SIZE 2-LEFT MED, 10MM;   k)	REF 1-10013-211, SIZE 2-LEFT MED, 11MM;   l)	REF 1-10013-213, SIZE 2-LEFT MED, 13MM;   m)	REF 1-10013-259, SIZE 2-RIGHT MED, 9MM;   n)	REF 1-10013-260, SIZE 2-RIGHT MED, 10MM;   o)	REF 1-10013-261, SIZE 2-RIGHT MED, 11MM;   p)	REF 1-10013-263, SIZE 2-RIGHT MED, 13MM;   q)	REF 1-10013-309, SIZE 3-LEFT MED, 9MM;   r)	REF 1-10013-310, SIZE 3-LEFT MED, 10MM;   s)	REF 1-10013-311, SIZE 3-LEFT MED, 11MM;   t)	REF 1-10013-313, SIZE 3-LEFT MED, 13MM;   u)	REF

## 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-1673-2023
- **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-1673-2023

## Citation

> AI Analytics. FDA recall Z-1673-2023. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1673-2023. Source: US FDA. Licensed CC0.

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