FDA Device recall Z-1319-2015
DUAFIT(R) PIP 0o CA SIZE 3, REF A60 SP003, STERILE R, Rx only
- FDA Device
- Class II
- terminated
- Published 2015-04-01
On 2015-04-01 the FDA classified a Class II recall of DUAFIT(R) PIP 0o CA SIZE 3, REF A60 SP003, STERILE R, Rx only by In2bones Sas, citing dimensional non-conformity leading to the impossibility to introduce the implant in the dedicated holder.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1319-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-03-09 |
| Published | 2015-04-01 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | In2bones Sas |
| Distribution | TN |
Product
DUAFIT(R) PIP 0o CA SIZE 3, REF A60 SP003, STERILE R, Rx only. Interphalangeal implant.
Reason
Dimensional non-conformity leading to the impossibility to introduce the implant in the dedicated holder.
Identifiers
| code_info | Batch numbers: 1412021 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1319-2015%22
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