FDA-Device2023-10-18Class II
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
Flower Orthopedics Corporation
Hazard
Device is breaking while in use, potential for patients to require a revision surgery.
Sold states
US Nationwide distribution.
Affected count
70 units
Manufactured in
100 Witmer Rd Ste 280, N/A, Horsham, PA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0074-2024Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief