Custom Made Implant System with Minimum Invasive Grower — Class II medical device recall Z-2567-2018
Terminated recall by Howmedica Osteonics Corp., reported 2018-08-08, distributed in FL, KS, NY. From March 2007 to October 2014, product did not contain updated instructions for use (IFU) to clarify the fun
| Recall number | Z-2567-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Howmedica Osteonics Corp., Mahwah, NJ, United States |
| Recall initiated | 2017-12-21 |
| Classified | 2018-07-28 |
| Reported by FDA | 2018-08-08 |
| Terminated | 2018-10-05 |
| Distributed | FL, KS, NY |
| Quantity | 5 |
Product
Custom Made Implant System with Minimum Invasive Grower (MIG) component
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2567-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.