Z-1698-2021Class II

T25 Cannulated Screwdrivers (CSD 025) packaged in Guide Wire Kits (GWK 300) -

Name: Z-1698-2021 T25 Cannulated Screwdrivers (CSD 025) packaged in Guide Wire Kits (GWK 300) -
Creator: Flower Orthopedics Corporation
Published: 2021-04-15
License: https://open.fda.gov/license/

FLOWER ORTHOPEDICS Corporation dba Conventus Flower / initiated 2021-04-15 / Terminated / root cause: manufacturing process

FDA source

Flower Orthopedics Corporation began a recall of T25 Cannulated Screwdrivers (CSD 025) packaged in Guide Wire Kits (GWK 300) - Product Usage: Intended to be used to insert screws with T25 driving features... on 2021-04-15. FDA classified it as Class II and gives the reason as "Cannulated Screwdrivers may break at the driver tip along the shaft, near the handle extending surgery time and additional x-ray to identify the fragments from the breakages". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1698-2021
Classification: Class II
Status: Terminated
Initiated: 2021-04-15
Posted: 2021-06-01
Terminated: 2021-11-12
Recalling firm: FLOWER ORTHOPEDICS Corporation dba Conventus Flower
Product: T25 Cannulated Screwdrivers (CSD 025) packaged in Guide Wire Kits (GWK 300) - Product Usage: Intended to be used to insert screws with T25 driving features, which includes screws with diameters of 5.5mm, 6.5mm, and 7.3mm Product Code: GWK 300
Product code: HXX Screwdriver
Reason for recall: Cannulated Screwdrivers may break at the driver tip along the shaft, near the handle extending surgery time and additional x-ray to identify the fragments from the breakages
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Flower Orthopedic issued Urgent Recall Information via email on 4/15/21. Letter states reason for recall, health risk and action to take: Check your inventory for the product listed below and quarantine immediately. Next, please complete and return the attached Acknowledgement and Receipt Form as soon as possible. Flower Orthopedics is initiating shipment of replacement product for delivery Friday April 16. Contact information for questions: Monday through Friday, 8:30 AM to 5:00 PM, EDST 877-778-8587 or [email protected] "Acknowledgement and Product Replacement Forms (see attached)
Quantity in commerce: 47 units
Distribution: US Nationwide distribution in the states of AZ, CO, FL, GA, IL, IN, PA, NC, VA.
Product codes and lots: Lot Numbers: 2003320898, 1810220041, 1802220008, 1802220005, 1711220035 UDI: 00840118110853

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1698-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1698-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-01

Product code HXX

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)