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Terminated

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

FDA Recall Z-1834-2017 · Posted 2017-04-17

Recalling FirmSignal Medical Corporation
Recall StatusTerminated
Product CodeGFJ
Date Initiated2017-02-20
Date Terminated2017-08-25
Product Quantity1,640

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.

Firm 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.

Root Cause

Labeling design

Distribution Pattern

Nationwide Distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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