Z-0074-2024Class II

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

Name: Z-0074-2024 Coventus Flower Orthopedics Flex-Thread TM 3.2mm Cannulated Reamer-used to ream and subsequently open the...
Creator: Flower Orthopedics Corporation
Published: 2023-08-29
License: https://open.fda.gov/license/

FLOWER ORTHOPEDICS Corporation dba Conventus Flower / initiated 2023-08-29 / Open, Classified

FDA source

Flower Orthopedics Corporation began a recall of Coventus Flower Orthopedics Flex-Thread TM 3.2mm Cannulated Reamer-used to ream and subsequently open the intramedullary canal to the appropriate depth for... on 2023-08-29. FDA classified it as Class II and gives the reason as "Device is breaking while in use, potential for patients to require a revision surgery". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0074-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-08-29
Posted: 2023-10-06
Recalling firm: FLOWER ORTHOPEDICS Corporation dba Conventus Flower
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
Product code: HSB Rod, Fixation, Intramedullary And Accessories
Reason for recall: Device is breaking while in use, potential for patients to require a revision surgery.
FDA root cause: Under Investigation by firm
Action: Flowers initiated communication via email with a quarantine form on 08/29/2023. A notification packet detailing parameters of recall was issued on (09/1/2023) via certified mail. Letter states reason for recall, health risk and action to take: Immediately quarantine lot 2304323076 if not already segregated after quarantine notice sent on 08/28/2023. Return Product to Conventus Flower headquarters at 100 Witmer Rd Suite 280, Horsham, PA 19044. This advisory notice only includes the lot identified above. It does NOT affect other lots. You must acknowledge this notice by returning the attached Acknowledgement and Receipt Form by mail or by email at [email protected]. For further information contact Christina Rovaldi, Sr. Manager RA/QA [email protected]. Return the attached Acknowledgement and Receipt Form mail or by email to [email protected]. Company contact hours are Monday through Friday, 8:30 AM to 5:00 PM, Eastern Time
Quantity in commerce: 70 units
Distribution: US Nationwide distribution.
Product codes and lots: UDI:00840118117432 Lot Number: 2304323076

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0074-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0074-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-10-18	2023-10-06

Product code HSB

K202858Class IIFlex-ThreadTM Distal Fibula Intramedullary Nail SystemConventus Orthopaedics, LLC / cleared 2021-01-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)