Flower Orthopedics Corporation recalls Coventus Flower Orthopedics Flex-Thread TM 3.2mm Cannulated Reamer-used to ream and subsequently open the intramedullar…

Recall date

August 29, 2023

Source

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

Recall number

Z-0074-2024

FDA classification

Class II

Brand / firm

Flower Orthopedics Corporation

Sold / distributed

US Nationwide distribution.

Why it was recalled

Device is breaking while in use, potential for patients to require a revision surgery.

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

What was recalled

Coventus Flower Orthopedics Flex-Thread TM 3.2mm Cannulated Reamer-used to ream and subsequently open the intramedullary canal to the appropriate depth for nail insertion; Flex-Thread TM 3.2mm is provided sterile, single use. Catalogue Number: 8528-1-S