FDA recall Z-1649-2022

Product

Metalogix Self-Drill Half-Pin, a component of the Revolution External Fixation System. Orthopedic. Metalogix Self-Drill Half-Pin 5x30x215mm REF 620030 Metalogix Self-Drill Half-Pin 5x40x215mm REF 620040 Metalogix Self-Drill Half-Pin 5x60x215mm REF 620060 Metalogix Self-Drill Half-Pin 5x80x215mm REF 620080

Reason for recall

Complaints were received for Self-drill Half-Pin tip breakages occurring during surgery.

Distribution

U.S.: AZ, GA, IL MT, NC, NJ, NV, OH, PA, TX, and VA O.U.S.: None

Key facts

Status

Ongoing

Initiation date

2020-12-28

Report date

2022-09-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

San Antonio, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1649-2022