Pro-dex, Inc.
2361 McGaw Avenue, Irvine, CA, US
Registered product codes
9 product codes
Recent MDR events
0 on file
No MDR events on file for this firm name.
Recalls
7 on file
- Open, ClassifiedOct 31, 2024
The packaging of a sterile battery, intended to power a surgical screwdriver, may contain Tyvek shavings inside the sterile package.
View FDA record ↗ - Open, ClassifiedJul 5, 2023
Battery packs used in surgical procedures where a surgeon uses a powered screwdriver and a right-angle attachment have switched manufacturing and expiration dates on sterile pouch labels, so batteries will appear to be prematurely expired.
View FDA record ↗ - Open, ClassifiedApr 14, 2023
Incorrect Unique Device Identifier/GTIN code was used on product.
View FDA record ↗ - TerminatedMar 11, 2016
The sterile battery may contain particulates within the sterile package.
View FDA record ↗ - TerminatedMar 11, 2016
The sterile battery may contain particulates within the sterile package.
View FDA record ↗ - TerminatedMar 26, 2010
Pro-Dex has initiated a recall on their Dental Torque Wrench. The recall was initiated due to an inaccurate laser etch identification of the torque value.
View FDA record ↗ - TerminatedUnknown
Visual particulates within a battery Tyvek pouch. The battery is provided sterile for use with surgical drivers.
View FDA record ↗
Compliance history
Matched by FEI 2081135.
FDA inspections
0 on file
No inspections on file for this FEI number.
Inspection citations
0 on file
No citations on file for this FEI number.
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.