Z-1391-2023Class II

KLS martin Group KLS E-COUPLING ADAPTER REF PDEC-1000-2 E-Coupling Adapter Assembly used to connect the KLS...

Name: Z-1391-2023 KLS martin Group KLS E-COUPLING ADAPTER REF PDEC-1000-2 E-Coupling Adapter Assembly used to connect the KLS...
Creator: Pro-Dex Inc
Published: 2023-02-14
License: https://open.fda.gov/license/

Pro-Dex Inc / initiated 2023-02-14 / Open, Classified / root cause: labeling and UDI

FDA source

Pro-Dex Inc began a recall of KLS martin Group KLS E-COUPLING ADAPTER REF PDEC-1000-2 E-Coupling Adapter Assembly used to connect the KLS driver (e.g. drill) to a driver bit that fits into... on 2023-02-14. FDA classified it as Class II and gives the reason as "Incorrect Unique Device Identifier/GTIN code was used on product". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1391-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-02-14
Posted: 2023-04-14
Recalling firm: Pro-Dex Inc
Product: KLS martin Group KLS E-COUPLING ADAPTER REF PDEC-1000-2 E-Coupling Adapter Assembly used to connect the KLS driver (e.g. drill) to a driver bit that fits into the adapter.
Product code: GET Motor, Surgical Instrument, Pneumatic Powered
Reason for recall: Incorrect Unique Device Identifier/GTIN code was used on product.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: On or about 11/08/2022, the firm contacted its customer to inform them that the Unique Device Identifier (UDI/GTIN) code was incorrectly utilized for the the Pro-Dex E-Coupling Adapter Assembly. Customers are instructed to: Immediately cease distribution and us of the affected products. Inventory and distribution records should be evaluated immediately to ensure that affected Return the affected products to Returns Department (Recall CAPA-22-015) Pro-Dex, Inc. 2361 McGaw Avenue Irvine, California 92614 USA Reference the "Recall CAPA-22-015" on the outside of the shipping box For questions or concerns, contact the QARA group at Pro-Dex at 949-769-3200 or email [email protected]
Quantity in commerce: 199 devices
Distribution: U.S. Nationwide distribution in the state of FL.
Product codes and lots: Reference Number: PDEC-1000-2 Part Number: A9671 Lot Numbers: K0C1B, K0D3P, K0E8T, K0FSD, K0HGV

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1391-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1391-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-26	2023-04-14

Product code GET

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)