FDA-Device2025-03-05Class II
A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 8H RT: Anatomic Lateral Fibula Plate, 8-hole, Right Indicated for use in Fixation of fractures of the distal tibia Model/Catalog Number: 77070802
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
212 units
Manufactured in
83 S Commerce Way Ste 310, N/A, Bethlehem, PA, United States
Products
A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 8H RT: Anatomic Lateral Fibula Plate, 8-hole, Right Indicated for use in Fixation of fractures of the distal tibia Model/Catalog Number: 77070802
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1214-2025Don't want to check this manually?
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