Recall Z-1318-2015 ยท HWC Screw, Fixation, Bone
In2Bones, SAS
DUAFIT(R) PIP 0o CA SIZE 2, REF A60 SP002, STERILE R, Rx only. Interphalangeal implant.
| Date | Mar 25, 2015 (initiated Mar 9, 2015) |
| Status | Terminated |
| Reason | Dimensional non-conformity leading to the impossibility to introduce the implant in the dedicated holder. |
| Root cause | Nonconforming Material/Component |
| Action | The firm notified their sole consignee in the US by email on 03/09/2015 requesting the return of the product, and to notify his consignee(s) to quarantine the unused product. |
| Quantity | 35 units |
| Distribution | Distributed in the state of TN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132912 | DUAFIT INTERGPHALANGEAL IMPLANT, PEEK-FUSE INTERPHALANGEAL IMPLANT In2bones Sas, Jul 30, 2014 |