Device product
Soft Face "No Bounce" Mallet Model/Catalog: BIO-1-1090
Z-1834-2017
Product summary
- Event
- Event 76509
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,640
- Official record key
device-enforcement:Z-1834-2017
Official wording
Reason: 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.
Code information: All units in distribution
Distribution pattern: Nationwide Distribution.
Derived failure modes
-
Foreign material or chemical contamination
foreign material