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Recall Observatory FDA recall evidence

Device 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.

Z-1391-2023

February 14, 2023

Class II

Product summary

Firm
Pro-Dex Inc
Event
Event 91850
Status
Ongoing
Classification
Class II
Quantity
199 devices
Official record key
device-enforcement:Z-1391-2023

Official wording

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

Code information: Reference Number: PDEC-1000-2 Part Number: A9671 Lot Numbers: K0C1B, K0D3P, K0E8T, K0FSD, K0HGV

Distribution pattern: U.S. Nationwide distribution in the state of FL.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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