Signal Medical Soft Face Mallet Recalled for Tip Detachment Risk
Signal Medical Corporation is recalling 1,640 Soft Face "No Bounce" Mallets because the poly tip may detach during use, posing a risk of foreign material in the surgical field.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a risk of harm (foreign material in the surgical field or surgery delay) where specific injury reports are not stated in the source text, fitting the criteria for a High severity score.
Plain-English summary
Signal Medical Corporation is recalling 1,640 units of the Soft Face "No Bounce" Mallet, Model/Catalog BIO-1-1090. The recall was initiated because the poly tip of the mallet has the potential to come off during use. This defect could result in foreign material entering the surgical field or cause a delay in surgery.
The affected units were distributed nationwide. The recall covers all units in distribution. The notice also serves as a reminder to customers that the poly tip must be removed for cleaning and sterilization to ensure the entire mallet is properly processed.
Customers should stop using the affected mallets and contact Signal Medical Corporation for further instructions regarding the recall.
The recalled product
- Product
- Soft Face "No Bounce" Mallet Model/Catalog: BIO-1-1090
- Manufacturer
- Signal Medical Corporation
- Affected units
- 1,640
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All units in distribution
Distribution
Distributed nationwide across the United States.
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