# FDA recall Z-3100-2017

> **Smith & Nephew, Inc.** · Class II · device recall initiated 2017-07-24.

## Product

smith&nephew POLARSTEM(TM) Femoral Stems with Ti/HA (Standard, Lateral, Valgus and Collar), REF 76102260, NON STERILE, QTY: (1), Rx only  The subject cardan is used in conjunction with a curved stem impactor used to implant the POLARSTEM hip stem. The hip stem is mounted on the screw at the tip of the instrument, and the stem is then impacted into the femur. After impaction, the surgeon uses a knob at the end of the cardan to unscrew the implanted stem from the instrument

## Reason for recall

The Cardan joint of the Polarstem Cardan could potentially fracture or functionally fail after multiple procedures.

## Distribution

Worldwide Distribution - US (Nationwide) and Internationally to Australia, Belgium, Norway, and Switzerland.

## Key facts

- **Recall number:** Z-3100-2017
- **Recalling firm:** Smith & Nephew, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-07-24
- **Report date:** 2017-09-06
- **Termination date:** 2020-08-21

- **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-3100-2017

## Citation

> AI Analytics. FDA recall Z-3100-2017. Retrieved 2026-06-04 from https://api.ai-analytics.org/recall/Z-3100-2017. Source: US FDA. Licensed CC0.

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