FDA Medical Device Recalls (openFDA)
Howmedica Osteonics Corp.: Custom Made Implant System with Minimum Invasive Grower (MIG) component
- Recall number
- Z-2567-2018
- Recalling firm
- Howmedica Osteonics Corp.
- Product
- Custom Made Implant System with Minimum Invasive Grower (MIG) component
- Status
- Terminated
- Initiated
- 2017-12-21
- Posted
- not on file
- Terminated
- 2018-10-05
- Reason
- 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.
- Root cause
- Labeling design
- 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.
- Quantity
- 5
- Distribution
- NY, FL, KS
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JDO
- Firm FEI
- 3003070421
- Firm city
- Mahwah
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28