Recall Z-1391-2023 ยท GET Motor, Surgical Instrument, Pneumatic Powered
Pro-Dex Inc
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.
| Date | Apr 14, 2023 (initiated Feb 14, 2023) |
| Status | Open, Classified |
| Reason | Incorrect Unique Device Identifier/GTIN code was used on product. |
| 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 question |
| Quantity | 199 devices |
| Distribution | U.S. Nationwide distribution in the state of FL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.