Recall Z-1318-2015
In2Bones, SAS · initiated March 9, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
DUAFIT(R) PIP 0o CA SIZE 2, REF A60 SP002, STERILE R, Rx only. Interphalangeal implant.
Codes / lots: Batch numbers: 1404032, 1412011
Reason for recall
Dimensional non-conformity leading to the impossibility to introduce the implant in the dedicated holder.
FDA-determined cause: Nonconforming Material/Component
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.
Details
- Recall number
- Z-1318-2015
- Initiated
- March 9, 2015
- Posted by FDA
- March 25, 2015
- Terminated
- May 19, 2016
- Product code
- HWC – Screw, Fixation, Bone
- Quantity
- 35 units
- Distribution
- Distributed in the state of TN.
- Recalling firm
- In2Bones, SAS, Ecully
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1319-2015 Class II | DUAFIT(R) PIP 0o CA SIZE 3, REF A60 SP003, STERILE R, Rx only. Interphalangeal implant.Dimensional non-conformity leading to the impossibility to introduce the implant in the dedicated holder. | 03/09/2015Terminated |