Z-0531-2022Class II

8mm FlexDex Needle Driver, Product Code FD-335 ND

Name: Z-0531-2022 8mm FlexDex Needle Driver, Product Code FD-335 ND
Creator: FlexDex Inc.
Published: 2021-12-22
License: https://open.fda.gov/license/

FlexDex Inc. / initiated 2021-12-22 / Terminated / root cause: labeling and UDI

FDA source

FlexDex Inc. began a recall of 8mm FlexDex Needle Driver, Product Code FD-335 ND on 2021-12-22. FDA classified it as Class II and gives the reason as "The firm is reinforcing the IFU instructions: "Do not use if the package is damaged." If upon inspection of the packaging, any damage is observed, including pinholes or tears in the pouch, the product should not be used". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0531-2022
Classification: Class II
Status: Terminated
Initiated: 2021-12-22
Posted: 2022-01-27
Terminated: 2023-07-25
Recalling firm: FlexDex Inc.
Product: 8mm FlexDex Needle Driver, Product Code FD-335 ND
Product code: MDM Instrument, Manual, Surgical, General Use
Reason for recall: The firm is reinforcing the IFU instructions: "Do not use if the package is damaged." If upon inspection of the packaging, any damage is observed, including pinholes or tears in the pouch, the product should not be used.
Root cause tag: labeling and UDI
FDA root cause: Unknown/Undetermined by firm
Action: The firm sent a letter to customers reiterating the IFU's statement "Do not use if package is damaged." This is important to ensure the sterility of the product. If upon inspection of the packaging, any damage is observed, including pinholes or tears in the pouch, the product should not be used. Please forward this letter on to all those who need to be aware within your organization and to any other organizations (e.g. customers) on which this has an impact.
Quantity in commerce: 273
Distribution: n/a
Product codes and lots: All lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0531-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0531-2022	Class II	Terminated	Voluntary: Firm initiated	2022-02-02	2022-01-27

Product code MDM

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)