FDA-Device2018-09-12Class II
Peg Fully Threaded, Locking, 2.5mm x 10mm, Item Number 131212610 Orthopedic device used for stabilization and fixation of small bone fragments Intended for stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions of small bones of the hand, foot, wrist, ankle, humerus, scapula, finger, toe, pelvis and craniomaxillofacial skeleton, particularly in osteopenic bone.
Zimmer Biomet, Inc.
Hazard
A size 22mm threaded peg was found in the package of a 10mm unit.
Sold states
International Distribution to countries of: Japan and Netherlands.
Affected count
25 units
Manufactured in
56 E Bell Dr, N/A, Warsaw, IN, United States
Products
Peg Fully Threaded, Locking, 2.5mm x 10mm, Item Number 131212610 Orthopedic device used for stabilization and fixation of small bone fragments Intended for stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions of small bones of the hand, foot, wrist, ankle, humerus, scapula, finger, toe, pelvis and craniomaxillofacial skeleton, particularly in osteopenic bone.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2965-2018Don't want to check this manually?
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