Device product
DUAFIT(R) PIP 0o CA SIZE 2, REF A60 SP002, STERILE R, Rx only. Interphalangeal implant.
Z-1318-2015
Product summary
- Firm
- In2Bones, SAS
- Event
- Event 70736
- Status
- Terminated
- Classification
- Class II
- Quantity
- 35 units
- Official record key
device-enforcement:Z-1318-2015
Official wording
Reason: Dimensional non-conformity leading to the impossibility to introduce the implant in the dedicated holder.
Code information: Batch numbers: 1404032, 1412011
Distribution pattern: Distributed in the state of TN.
Derived failure modes
-
Unknown
Dimensional non-conformity leading to the impossibility to introduce the implant in the dedicated holder.