Synthes, Inc. recalls 3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws; . the Cannulated Screws are indicated for fixation…

Recall date

May 13, 2015

Source

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

Recall number

Z-1800-2015

FDA classification

Class II

Brand / firm

Synthes, Inc.

Sold / distributed

Nationwide Distribution

Why it was recalled

Certain lots of the 3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws were found to have been labeled incorrectly.

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

What was recalled

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.