Signal Medical Corporation: Medical Device Recall in 2017 - (Recall #: Z-1834-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: February 20, 2017

Date Posted: April 26, 2017

Recall Number: Z-1834-2017

Event ID: 76509

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.

Status: Terminated

Product Quantity: 1,640

Code Information:

All units in distribution

Distribution Pattern:

Nationwide Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated