Custom Made Implant System with Minimum Invasive Grower recall
Custom Made Implant System with Minimum Invasive Grower (MIG) component
Why was Custom Made Implant System with Minimum Invasive Grower 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Custom Made Implant System with Minimum Invasive Grower (MIG) component
- Recalling firm
- Howmedica Osteonics Corp.
- Quantity
- 5
- Distribution
- NY, FL, KS
- Recall date
- August 8, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)