GMK Intramedullary Extension Rod 100 mm is a rod to obtain correct… — Class II medical device recall Z-0202-2015
Terminated recall by Medacta Usa, reported 2014-11-19. Medacta has registered in its database 3 cases of breakage of the GMK Intramedullary Extension Rod 100 mm, cod
| Recall number | Z-0202-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medacta Usa, Chicago, IL, United States |
| Recall initiated | 2014-09-22 |
| Classified | 2014-11-12 |
| Reported by FDA | 2014-11-19 |
| Terminated | 2015-05-07 |
| Countries outside the US | AT, AU, BE, CH, DE, ES, FR, GR, IT, JP, PT, ZA |
| Reason classes | device malfunction |
| Model numbers | 0162 |
Product
GMK Intramedullary Extension Rod 100 mm is a rod to obtain correct leg alignment during total knee replacement. Rod to obtain correct leg alignment during total knee replacement.
Reason for recall
Medacta has registered in its database 3 cases of breakage of the GMK Intramedullary Extension Rod 100 mm, code 02.07.10.0162.
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-0202-2015. 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.