Recall Z-0074-2024— Flower Orthopedics Corporation

Name: FDA recall Z-0074-2024
Creator: U.S. Food and Drug Administration
Published: 2023-08-29

Class II · Ongoing

Class II FDA medical device recall by Flower Orthopedics Corporation, initiated 2023-08-29. It names one FDA 510(k) clearance: K202858. 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: Device is breaking while in use, potential for patients to require a revision surgery..

Recalling firm: Flower Orthopedics Corporation
Classification: Class II
Status: Ongoing
Initiated: 2023-08-29
Firm location: Horsham, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K202858 — Flex-ThreadTM Distal Fibula Intramedullary Nail SystemConventus Orthopaedics, LLC·cleared 2021-01-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.