FDA recall Z-1467-2023

Wright Medical Technology, Inc. · Class II · device

Product

stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A221RT, bone stabilization and fixation

Reason for recall

Two lots of Ortholoc 3Di Fusion plates contain incorrect dorsiflexion descriptions laser marked on the parts.

Distribution

US Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2023-04-10
Report date
2023-05-03
Voluntary/Mandated
Voluntary: Firm initiated
Location
Memphis, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1467-2023