FDA recall Z-1239-2018

Product

Coonrad/Morrey Elbow Implant System humeral assembly 4IN XSML, Item Number: 32-8105-027-04 (UDI: (01)0088902427 4006(17)220731(10)63694912)

Reason for recall

One lot of humeral stem implants do not include the humeral bushing components.

Distribution

Distributed in China and Taiwan.

Key facts

Status

Terminated

Initiation date

2018-01-24

Report date

2018-04-04

Termination date

2019-04-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1239-2018