Zimmer Biomet, Inc. recalls Peg Fully Threaded, Locking, 2.5mm x 10mm, Item Number 131212610 Orthopedic device used for stabilization and fixation…

Recall date

July 12, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2965-2018

FDA classification

Class II

Brand / firm

Zimmer Biomet, Inc.

Sold / distributed

International Distribution to countries of: Japan and Netherlands.

Why it was recalled

A size 22mm threaded peg was found in the package of a 10mm unit.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.