Z-1834-2017Class II

Soft Face "No Bounce" Mallet Model/Catalog: BIO-1-1090

Name: Z-1834-2017 Soft Face "No Bounce" Mallet Model/Catalog: BIO-1-1090
Creator: Signal Medical Corporation
Published: 2017-02-20
License: https://open.fda.gov/license/

Whiteside Biomechanics, Inc. / initiated 2017-02-20 / Terminated / root cause: labeling and UDI

FDA source

Signal Medical Corporation began a recall of Soft Face "No Bounce" Mallet Model/Catalog: BIO-1-1090 on 2017-02-20. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1834-2017
Classification: Class II
Status: Terminated
Initiated: 2017-02-20
Posted: 2017-04-17
Terminated: 2017-08-25
Recalling firm: Whiteside Biomechanics, Inc.
Product: Soft Face "No Bounce" Mallet Model/Catalog: BIO-1-1090
Product code: GFJ Mallet, Surgical, General & Plastic Surgery
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: On 2/20/2016, URGENT: MEDICAL DEVICE RECALL notifications dated February 10, 2017 were sent to the affected consignees via e-mail. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Customers are to retain the notice and replace the old Instructions For Use with the updated version. Also, they are to acknowledge receipt of the instructions by signing the notice and emailing to [email protected] or faxing to 810-364-7072. The firm has attached the revised labeling to the letter.
Quantity in commerce: 1,640
Distribution: Nationwide Distribution.
Product codes and lots: All units in distribution

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1834-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1834-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-26	2017-04-17

Product code GFJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)