Z-1834-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 26, 2017
- Initiation Date
- February 20, 2017
- Termination Date
- August 25, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,640
Product Description
Soft Face "No Bounce" Mallet Model/Catalog: BIO-1-1090
Reason for Recall
Potential for poly tip of the mallet to come off during use. Potential for foreign material in the surgical field or delay in surgery. Reminder for customers that the poly tip must be removed for cleaning and sterilization to assure proper cleaning and sterilization of the entire mallet.
Distribution Pattern
Nationwide Distribution.
Code Information
All units in distribution