FDA recall Z-2109-2023

Product

Allen Advance Chest Support with Pad

Reason for recall

Potential for the device to crack where the Chest Base Prone support attaches to the carbon fiber operating room (OR) table rail.

Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Australia, China, Hong Kong, India, Japan, Korea, Malaysia, Singapore, Taiwan, Thailand, Belgium, Croatia, Denmark, Egypt, France, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Netherlands, Norway, Poland, Qatar, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates and United Kingdom.

Key facts

Status

Ongoing

Initiation date

2023-05-18

Report date

2023-07-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2109-2023