Non-Sterile Double Ended Trial Kit recalled over sterility concerns

Recall date

March 30, 2022

Source

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

Official notice title

restor3d Inc. recalls Non-Sterile Double Ended Trial Kit, Small Footprint, (6110-N01-KTS01) for the Cervical Cage. The kit includes 3 trials.…

Recall number

Z-1026-2022

FDA classification

Class II

Brand / firm

restor3d Inc.

Sold / distributed

US Nationwide distribution in the states of KY, NC, NJ, TX, IN, VA and AL.

Why it was recalled

Product labeled incorrectly. The lot was labeled with Small footprint when the product was Medium.

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

What was recalled

Non-Sterile Double Ended Trial Kit, Small Footprint, (6110-N01-KTS01) for the Cervical Cage. The kit includes 3 trials. Orthopedic manual surgical instrument