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Terminated

Custom Made Implant System with Minimum Invasive Grower (MIG) component

FDA Recall Z-2567-2018 · Posted None

Recalling FirmHowmedica Osteonics Corp.
Recall StatusTerminated
Product CodeJDO
Date Initiated2017-12-21
Date Terminated2018-10-05
Product Quantity5

Reason for Recall

From March 2007 to October 2014, product did not contain updated instructions for use (IFU) to clarify the function of locking mechanism and warnings related to the locking screw.

Firm Action

On December 21, 2017 a FIELD SAFETY NOTICE was issued to customers notifying of the corrective action. An attachment was supplied with the letter titled "Minimally Invasive Grower - Instructions For Adjustment that is effective on and after October 14, 2014. Questions or concerns can be directed to your local sales representative.

Root Cause

Labeling design

Distribution Pattern

NY, FL, KS

Official Source

View FDA Recall →

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

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