FDA recall Z-1543-2020

Product

Comprehensive Shoulder System Mini Humeral Stem 9mm,, Model No. 113629 - Product Usage: The intended use of the comprehensive humeral stem mini is to act as the humeral component of the comprehensive total shoulder system.

Reason for recall

A 15mm Shoulder Mini Humeral Stem was misidentified as a 9mm Shoulder Mini Humeral Stem.

Distribution

International distribution in the countries of Canada, Japan, Netherlands, South Korea.

Key facts

Status

Terminated

Initiation date

2020-02-17

Report date

2020-04-01

Termination date

2022-05-31

Voluntary/Mandated

Voluntary: Firm initiated

Location

Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1543-2020