Reported Aug 8, 2018 · Terminated
Custom Made Implant System with Minimum Invasive Grower (MIG) component
Howmedica Osteonics Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Howmedica Osteonics Corp. · 325 Corporate Dr · Mahwah, NJ · 07430-2006
Is this the product you have?
- Custom Made Implant System with Minimum Invasive Grower (MIG) component
- Lot codes and dates
- Manufactured between March 2007 and October 2014 Prosthesis Identification Number (PIN) Date of Dispatch 16082 11Apr 2011 18313 19 Dec 2013 18666 20 Jun 2014 18713 15 Sep 2014 18800 29 Aug 2014
- Amount recalled
- 5
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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