Z-1319-2015 Class II Terminated
FDA device recall Z-1319-2015 was initiated by In2Bones, SAS on March 9, 2015 and is designated Class II. Reason for recall: Dimensional non-conformity leading to the impossibility to introduce the implant in the dedicated holder. The recall status is terminated (terminated May 19, 2016). Affected quantity: 15 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 1, 2015
- Initiation Date
- March 9, 2015
- Termination Date
- May 19, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15 units
Product Description
DUAFIT(R) PIP 0o CA SIZE 3, REF A60 SP003, STERILE R, Rx only. Interphalangeal implant.
Reason for Recall
Dimensional non-conformity leading to the impossibility to introduce the implant in the dedicated holder.
Distribution Pattern
Distributed in the state of TN.
Code Information
Batch numbers: 1412021