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

FDA device recall Z-1834-2017 · posted 2017-04-17 · Terminated

Recall details

Recalling firm

Signal Medical Corporation

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.

Action taken

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 SignalMedical2017@gmail.com or faxing to 810-364-7072. The firm has attached the revised labeling to the letter.

Root cause

Labeling design

Status

Terminated

Product code

GFJ

Quantity affected

1,640

Distribution

Nationwide Distribution.

Date initiated

2017-02-20

Date posted

2017-04-17

Date terminated

2017-08-25

Location

Marysville, MI