Galaxy UNYCO for temporary stabilisation of lower limb fractures

Regulatory information

The Galaxy UNYCO system was CE marked as a class IIb device in May 2014.

A field safety notice for this technology was issued in May 2015. The field safety notice was a precautionary measure to avoid potentially defective power drill torque limiters for batch number V1375371 (product code 99‑93506). Hospitals were required to return any defective power drill torque limiters. The company has stated that this has been fully resolved and the incident has been closed by the Medicines and Healthcare products Regulatory Agency (MHRA). No patients or users were subject to any adverse incidents or outcomes. In June 2017, a second field safety notice was issued (FSCA201701) for the same reason.