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

Recalled October 18, 2023 · FDA recall Z-0074-2024 · Flower Orthopedics

Hazard

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

Units

70 units

Sold at

US Nationwide distribution.

Description

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

Product

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

Manufacturer(s)

Flower Orthopedics Corporation

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →