FDA recall Z-1011-2022

Product

Smart Toe II Intramedullary Arthrodesis Implant

Reason for recall

The nickel-sensitivity statement on the outer carton may be partially covered by a label resulting in the statement showing "Indicated for patients with Nickel sensitivity" instead of "Not Indicated for patients with Nickel sensitivity".

Distribution

Worldwide distribution - US Nationwide and the countries including Australia, Canada, Chile, China, France, Germany, Netherlands, New Zealand, Spain, Sweden, Switzerland, and United Kingdom.

Key facts

Status

Ongoing

Initiation date

2022-03-28

Report date

2022-05-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Selzach, Switzerland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1011-2022