FDA recall Z-1638-2022

Product

Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental and multisegmental stabilization of the lumbar, thoracic and sacral spine. Article Number: 52758014

Reason for recall

Potential for the incorrect screw to be included in the package.

Distribution

GA, TX

Key facts

Status

Ongoing

Initiation date

2022-07-15

Report date

2022-09-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1638-2022