Recall Z-1834-2017— Signal Medical Corporation
Class II · Terminated
Class II FDA medical device recall by Signal Medical Corporation, initiated 2017-02-20, terminated 2017-08-25. FDA's recall record names no specific 510(k) clearance for this event. Product: Soft Face "No Bounce" Mallet Model/Catalog: BIO-1-1090. 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..
- Recalling firm
- Signal Medical Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-02-20
- Terminated
- 2017-08-25
- Firm location
- Marysville, MI, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.