Soft Face "No Bounce" Mallet recall: Foreign Material
Soft Face "No Bounce" Mallet Model/Catalog: BIO-1-1090
Why was Soft Face "No Bounce" Mallet recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All units in distribution
- Product
- Soft Face "No Bounce" Mallet Model/Catalog: BIO-1-1090
- Recalling firm
- Signal Medical Corporation
- Quantity
- 1,640
- Distribution
- Nationwide Distribution.
- Recall date
- April 26, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)