DUAFIT(R) PIP 0o CA SIZE 3, REF A60 SP003, STERILE R, Rx only. Interphalangeal implant.
FDA device recall Z-1319-2015 · posted 2015-03-25 · Terminated
Recall details
- Recalling firm
- In2Bones, SAS
- Reason for recall
- Dimensional non-conformity leading to the impossibility to introduce the implant in the dedicated holder.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- HWC
- Quantity affected
- 15 units
- Distribution
- Distributed in the state of TN.
- Date initiated
- 2015-03-09
- Date posted
- 2015-03-25
- Date terminated
- 2016-05-19
- Location
- Ecully, France
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DUAFIT INTERGPHALANGEAL IMPLANT, PEEK-FUSE INTERPHALANGEAL IMPLANT (K132912) | In2bones Sas | 2014-07-30 |