FDA-Device2025-03-05Class II

A.L.P.S. mvX- Product Name: ANATOMIC LAT FIB PLATE 10H LT Anatomic Lateral Fibula Plate, 10-Hole, Left. Intended Fixation of fractures of the distal tibia Model/Catalog Number: 770708101

Tyber Medical
Hazard

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

Sold states
Nationwide
Affected count
220 units
Manufactured in
83 S Commerce Way Ste 310, N/A, Bethlehem, PA, United States
Products
A.L.P.S. mvX- Product Name: ANATOMIC LAT FIB PLATE 10H LT Anatomic Lateral Fibula Plate, 10-Hole, Left. Intended Fixation of fractures of the distal tibia Model/Catalog Number: 770708101

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1215-2025

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