Z-1095-2016 Class II Terminated
FDA device recall Z-1095-2016 was initiated by Pro-Dex Inc on December 23, 2015 and is designated Class II. Reason for recall: The sterile battery may contain particulates within the sterile package. The recall status is terminated (terminated July 21, 2017). Affected quantity: 1995 total.
Recall Details
- Product Type
- Devices
- Report Date
- March 23, 2016
- Initiation Date
- December 23, 2015
- Termination Date
- July 21, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1995 total
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.
Distribution Pattern
Distributed in FL.
Code Information
Lots 509567, K055R