FDAClass IIApril 1, 2015

Duafit(r) PIP 0o CA recall

DUAFIT(R) PIP 0o CA SIZE 2, REF A60 SP002, STERILE R, Rx only. Interphalangeal implant.

Why was Duafit(r) PIP 0o CA recalled?

Dimensional non-conformity leading to the impossibility to introduce the implant in the dedicated holder.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Batch numbers: 1404032, 1412011

Product
DUAFIT(R) PIP 0o CA SIZE 2, REF A60 SP002, STERILE R, Rx only. Interphalangeal implant.
Recalling firm
In2Bones, SAS
Quantity
35 units
Distribution
Distributed in the state of TN.
Recall date
April 1, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls