Soft Face "No Bounce" Mallet Model/Catalog: BIO-1-1090 — Class II medical device recall Z-1834-2017
Terminated recall by Signal Medical Corporation, reported 2017-04-26, distributed nationwide. Potential for poly tip of the mallet to come off during use. Potential for foreign material in the surgical fi
| Recall number | Z-1834-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Signal Medical Corporation, Marysville, MI, United States |
| Recall initiated | 2017-02-20 |
| Classified | 2017-04-17 |
| Reported by FDA | 2017-04-26 |
| Terminated | 2017-08-25 |
| Distributed | Nationwide (US) |
| Quantity | 1,640 |
| Reason classes | foreign material |
| Model numbers | BIO-1-1090 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1834-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.