Z-1834-2017 Class II Terminated
FDA device recall Z-1834-2017 was initiated by Signal Medical Corporation on February 20, 2017 and is designated Class II. 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 cle… The recall status is terminated (terminated August 25, 2017). Affected quantity: 1,640.
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