Recall Z-1319-2015— In2Bones, SAS

Name: FDA recall Z-1319-2015
Creator: U.S. Food and Drug Administration
Published: 2015-03-09

Class II · Terminated

Class II FDA medical device recall by In2Bones, SAS, initiated 2015-03-09, terminated 2016-05-19. It names one FDA 510(k) clearance: K132912. Product: DUAFIT(R) PIP 0o CA SIZE 3, REF A60 SP003, STERILE R, Rx only. Interphalangeal implant.. Reason: Dimensional non-conformity leading to the impossibility to introduce the implant in the dedicated holder..

Recalling firm: In2Bones, SAS
Classification: Class II
Status: Terminated
Initiated: 2015-03-09
Terminated: 2016-05-19
Firm location: Ecully, France

510(k) clearances named in this recall

1 on FDA's record

K132912 — DUAFIT INTERGPHALANGEAL IMPLANT, PEEK-FUSE INTERPHALANGEAL IMPLANTIn2bones Sas·cleared 2014-07-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.