Reported Apr 26, 2017 · Terminated
Soft Face "No Bounce" Mallet Model/Catalog: BIO-1-1090
Signal Medical Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Signal Medical Corporation · 400 Pyramid Dr · Marysville, MI · 48040-2463
Is this the product you have?
- Soft Face "No Bounce"
- Mallet Model/CatalogBIO-1-1090
- Lot codes and dates
- All units in distribution
- Amount recalled
- 1,640
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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