SAFE ORTHOPAEDICS LLC recalls SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws, model numbers/REF numbers KITM640, KITM645, and KITM740.

Recall date

June 3, 2022

Source

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

Recall number

Z-1572-2022

FDA classification

Class II

Brand / firm

SAFE ORTHOPAEDICS LLC

Sold / distributed

Distribution was made to MD. There was no government/military distribution.

Why it was recalled

The type of screw printed on the traceability record for the patient label is incorrect, but the type of screw printed on the other labeling is correct.

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

What was recalled

SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws, model numbers/REF numbers KITM640, KITM645, and KITM740.