Date Initiated by Firm |
February 14, 2023 |
Date Posted |
April 14, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1391-2023 |
Recall Event ID |
91850 |
Product Classification |
Motor, surgical instrument, pneumatic powered - Product Code GET
|
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. |
Code Information |
Reference Number: PDEC-1000-2
Part Number: A9671
Lot Numbers:
K0C1B,
K0D3P,
K0E8T,
K0FSD,
K0HGV |
Recalling Firm/ Manufacturer |
Pro-Dex Inc 2361 McGaw Ave Irvine CA 92614-5831
|
For Additional Information Contact |
Angel 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 |
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 Angel.Domingo@Pro-Dex.com
|
Quantity in Commerce |
199 devices |
Distribution |
U.S. Nationwide distribution in the state of FL. |
Total Product Life Cycle |
TPLC Device Report
|
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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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