PlainRecalls
FDA Devices Moderate Class II Terminated

DUAFIT(R) PIP 0o CA SIZE 3, REF A60 SP003, STERILE R, Rx only. Interphalangeal implant.

Reported: April 1, 2015 Initiated: March 9, 2015 #Z-1319-2015

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.

Details

Recalling Firm
In2Bones, SAS
Units Affected
15 units
Distribution
Distributed in the state of TN.
Location
Ecully

Frequently Asked Questions

What product was recalled?
DUAFIT(R) PIP 0o CA SIZE 3, REF A60 SP003, STERILE R, Rx only. Interphalangeal implant.. Recalled by In2Bones, SAS. Units affected: 15 units.
Why was this product recalled?
Dimensional non-conformity leading to the impossibility to introduce the implant in the dedicated holder.
Which agency issued this recall?
This recall was issued by the FDA Devices on April 1, 2015. Severity: Moderate. Recall number: Z-1319-2015.