CLASS II Device recall · Reported 26 Apr 2017 · FDA Enforcement Report
Soft Face "No Bounce" Mallet recalled by Signal Medical
Signal Medical is recalling Soft Face "No Bounce" Mallet, distributed nationwide in the US. The recall was initiated on 20 Feb 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1834-2017
- FDA event ID
- 76509
- Recalling firm
- Signal Medical, Marysville, MI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Feb 2017
- FDA classified
- 17 Apr 2017
- Reported
- 26 Apr 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Foreign Material
- Device type
- Other Medical Devices
Timeline
| 20 Feb 2017 | Recall initiated by company | |
| 17 Apr 2017 | Classified by FDA | +56 days |
| 26 Apr 2017 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Soft Face "No Bounce" Mallet Model/Catalog: BIO-1-1090
Where it was distributed
Nationwide Distribution.
Questions about this recall
Why was it 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.
Which lots are affected?
All units in distribution
Where was it sold?
Nationwide Distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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