DUAFIT(R) PIP 0o CA SIZE 2, REF A60 SP002, STERILE R, Rx only. Interphalangeal implant.
This recall has been terminated (originally issued March 25, 2015).
- Recall Initiated
- March 9, 2015
- Posted
- March 25, 2015
- Terminated
- May 19, 2016
- Recall Number
- Z-1318-2015
- Quantity
- 35 units
- Official Source
- View on FDA website ↗
Reason for Recall
Dimensional non-conformity leading to the impossibility to introduce the implant in the dedicated holder.
Distribution
Distributed in the state of TN.
Lot / Code Info
Batch numbers: 1404032, 1412011
Root 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.
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