Recall Z-1391-2023— Pro-Dex Inc

Name: FDA recall Z-1391-2023
Creator: U.S. Food and Drug Administration
Published: 2023-02-14

Class II · Ongoing

Class II FDA medical device recall by Pro-Dex Inc, initiated 2023-02-14. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Incorrect Unique Device Identifier/GTIN code was used on product..

Recalling firm: Pro-Dex Inc
Classification: Class II
Status: Ongoing
Initiated: 2023-02-14
Firm location: Irvine, CA, United States

Product description

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.

Reason for recall

Incorrect Unique Device Identifier/GTIN code was used on product.

Data sourced from openFDA. This site is unofficial and independent of the FDA.