FDA Device recall Z-1834-2017
Soft Face "No Bounce" Mallet Model/Catalog: BIO-1-1090
- FDA Device
- Class II
- terminated
- Published 2017-04-26
On 2017-04-26 the FDA classified a Class II recall of Soft Face "No Bounce" Mallet Model/Catalog: BIO-1-1090 by Signal Medical, citing 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 mus….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1834-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-02-20 |
| Published | 2017-04-26 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Signal Medical |
| Distribution | US |
Product
Soft Face "No Bounce" Mallet Model/Catalog: BIO-1-1090
Reason
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.
Identifiers
| code_info | All units in distribution |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1834-2017%22
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