FDA-Device2020-08-26Class II
DePuy Synthes Trauma LCP One-Third Tubular Plate with Collar 8 Holes / 93mm - Product Usage: intended for fixation of fractures, osteotomies and non-unions of clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia and fibula, particularly in osteopenic bone. Part Number 241.381
Synthes (USA) Products LLC
Hazard
May have one or more dimensional features out of tolerance includes: thread pitch diameter depth, thread minor diameter depth, plate thickness and end length out of tolerance that can potentially result in a reduced locking strength of an LCP screw
Sold states
US Nationwide distribution.
Affected count
191 units
Manufactured in
1301 Goshen Pkwy, N/A, West Chester, PA, United States
Products
DePuy Synthes Trauma LCP One-Third Tubular Plate with Collar 8 Holes / 93mm - Product Usage: intended for fixation of fractures, osteotomies and non-unions of clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia and fibula, particularly in osteopenic bone. Part Number 241.381
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2816-2020Don't want to check this manually?
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