# FDA recall Z-3104-2017

> **Stanmore Implants Worldwide Ltd.** · Class II · device recall initiated 2017-07-04.

## Product

JTS External Drive Unit    JTS Distal Femoral Extendible Implant Femur is intended for the replacement of diseased or deficient bone in the distal femur.

## Reason for recall

Three (3) complaints were identified  in which the potential for utilization of the JTS Grower Drive in the incorrect orientation in relation to the limb entry point of the device, together with the potential to select incorrect settings for the extension procedure. As a result, the prostheses in such cases failed to extend as intended.

## Distribution

US Distribution to the states of : CA, FL, GA, KS, MI, NJ, OH, PA, SC, and TX.

## Key facts

- **Recall number:** Z-3104-2017
- **Recalling firm:** Stanmore Implants Worldwide Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-07-04
- **Report date:** 2017-09-13
- **Termination date:** 2021-02-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Borehamwood, N/A, United Kingdom

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3104-2017

## Citation

> AI Analytics. FDA recall Z-3104-2017. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/Z-3104-2017. Source: US FDA. Licensed CC0.

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