FDA-Device2015-06-24Class II
3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws; . the Cannulated Screws are indicated for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, and fibula, particularly in osteopenic bone.
Synthes, Inc.
Hazard
Certain lots of the 3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws were found to have been labeled incorrectly.
Sold states
Nationwide Distribution
Affected count
54
Manufactured in
1302 Wrights Ln E, West Chester, PA, United States
Products
3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws; . the Cannulated Screws are indicated for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, and fibula, particularly in osteopenic bone.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1800-2015Don't want to check this manually?
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