DUAFIT — Class II medical device recall Z-1319-2015
Terminated recall by In2Bones, SAS, reported 2015-04-01, distributed in TN. Dimensional non-conformity leading to the impossibility to introduce the implant in the dedicated holder.
| Recall number | Z-1319-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | In2Bones, SAS, Ecully, France |
| Recall initiated | 2015-03-09 |
| Classified | 2015-03-25 |
| Reported by FDA | 2015-04-01 |
| Terminated | 2016-05-19 |
| Distributed | TN |
| Quantity | 15 units |
| Lot numbers | 1412021 |
| Model numbers | A60, SP003 |
Product
DUAFIT(R) PIP 0o CA SIZE 3, REF A60 SP003, STERILE R, Rx only. Interphalangeal implant.
Reason for recall
Dimensional non-conformity leading to the impossibility to introduce the implant in the dedicated holder.
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-1319-2015. 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.