Recall Z-1095-2016— Pro-Dex Inc
Class II · Terminated
Class II FDA medical device recall by Pro-Dex Inc, initiated 2015-12-23, terminated 2017-07-21. FDA's recall record names no specific 510(k) clearance for this event. Product: Battery Pack KLS-SD-1000 Single Models: KLS-BP-001 Used to power the KLS Martin Max Driver (battery powdered surgical screwdriver).. Reason: The sterile battery may contain particulates within the sterile package..
- Recalling firm
- Pro-Dex Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-12-23
- Terminated
- 2017-07-21
- Firm location
- Irvine, CA, United States
Product description
Battery Pack KLS-SD-1000 Single Models: KLS-BP-001 Used to power the KLS Martin Max Driver (battery powdered surgical screwdriver).
Reason for recall
The sterile battery may contain particulates within the sterile package.
Data sourced from openFDA. This site is unofficial and independent of the FDA.