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U.S. Department of Health and Human Services

Class 2 Device Recall ProDex ECoupling Adapter Assembly

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 Class 2 Device Recall ProDex ECoupling Adapter Assemblysee related information
Date Initiated by FirmFebruary 14, 2023
Date PostedApril 14, 2023
Recall Status1 Open3, Classified
Recall NumberZ-1391-2023
Recall Event ID 91850
Product Classification Motor, surgical instrument, pneumatic powered - Product Code GET
ProductKLS 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.
Code Information Reference Number: PDEC-1000-2 Part Number: A9671 Lot Numbers: K0C1B, K0D3P, K0E8T, K0FSD, K0HGV
FEI Number 2081135
Recalling Firm/
Manufacturer		 Pro-Dex Inc
2361 McGaw Ave
Irvine CA 92614-5831
For Additional Information ContactAngel Domingo
949-769-3200
Manufacturer Reason
for Recall		Incorrect Unique Device Identifier/GTIN code was used on product.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 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 Angel.Domingo@Pro-Dex.com
Quantity in Commerce199 devices
DistributionU.S. Nationwide distribution in the state of FL.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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