Z-0448-2022Class II

Flex-Thread Inserter Shaft intended for Fibula intramedullary-intended to be used with the Inserter Draw Rod...

Name: Z-0448-2022 Flex-Thread Inserter Shaft intended for Fibula intramedullary-intended to be used with the Inserter Draw Rod...
Creator: Flower Orthopedics Corporation
Published: 2021-11-02
License: https://open.fda.gov/license/

FLOWER ORTHOPEDICS Corporation dba Conventus Flower / initiated 2021-11-02 / Terminated / root cause: design

FDA source

Flower Orthopedics Corporation began a recall of Flex-Thread Inserter Shaft intended for Fibula intramedullary-intended to be used with the Inserter Draw Rod and Blue Ratchet Handle in order to facilitate the... on 2021-11-02. FDA classified it as Class II and gives the reason as "Mating incompatibility between the Inserter Shaft and the Inserter Draw Rod causing the inserter draw rod to bind and not rotate freely as intended surgeon may be unable to complete surgery unless a second set is...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0448-2022
Classification: Class II
Status: Terminated
Initiated: 2021-11-02
Posted: 2022-01-03
Terminated: 2023-10-12
Recalling firm: FLOWER ORTHOPEDICS Corporation dba Conventus Flower
Product: Flex-Thread Inserter Shaft intended for Fibula intramedullary-intended to be used with the Inserter Draw Rod and Blue Ratchet Handle in order to facilitate the insertion of the Flex-Thread Nail System- Catalog Number: 8435-1
Product code: HSB Rod, Fixation, Intramedullary And Accessories
Reason for recall: Mating incompatibility between the Inserter Shaft and the Inserter Draw Rod causing the inserter draw rod to bind and not rotate freely as intended surgeon may be unable to complete surgery unless a second set is available
Root cause tag: design
FDA root cause: Device Design
Action: Conventus Flower Orthopedics issued Urgent Recall Information letter dated 11/2/21 stating reason for recall, health risk and action to take: Check your inventory for the product listed below and immediately replace with the new product provided. 2.Next, please complete and return the attached Acknowledgement and ReceiptForm with the affected product in the provided packaging by November 5, 2021. Contact information for questions: Monday through Friday, 8:30 AM to 5:00 PM, EDST 877-778-8587 or [email protected]
Quantity in commerce: 48 units
Distribution: US Nationwide distribution in the states of AZ, CA, CO, GA, TN, FL, IL, MA, MD, NC, TX.
Product codes and lots: Lot Number: 11090 UDI: 00840118117548

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0448-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0448-2022	Class II	Terminated	Voluntary: Firm initiated	2022-01-12	2022-01-03

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)