FDA recall Z-1221-2025

Product

A.L.P.S. mvX- MEDIAL TIBIA PLATE 10H LT- Medial Tibia Plate, 10-Hole, Left. Intended Fixation of fractures of the distal tibia Model/Catalog Number: 770715101

Reason for recall

Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices

Distribution

Nationwide

Key facts

Status

Ongoing

Initiation date

2025-01-21

Report date

2025-03-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bethlehem, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1221-2025