Custom Made Device — Class II medical device recall Z-2732-2024
Ongoing recall by Howmedica Osteonics Corp., reported 2024-09-04. A patient specific, custom-made device was supplied for a surgical procedure that did not match the design pro
| Recall number | Z-2732-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Howmedica Osteonics Corp., Mahwah, NJ, United States |
| Recall initiated | 2024-08-05 |
| Classified | 2024-08-26 |
| Reported by FDA | 2024-09-04 |
| Countries outside the US | AU |
| Quantity | 1 units |
| Lot numbers | HX2H9A |
| Model numbers | C-MM100434-00 |
Product
Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Catalog Number: C-MM100434-00;
Reason for recall
A patient specific, custom-made device was supplied for a surgical procedure that did not match the design proposal.
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-2732-2024. 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.