FDA recall Z-0074-2024

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

Reason for recall

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

Distribution

US Nationwide distribution.

Key facts

Status

Ongoing

Initiation date

2023-08-29

Report date

2023-10-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Horsham, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0074-2024