Z-1318-2015Class II

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

Name: Z-1318-2015 DUAFIT(R) PIP 0o CA SIZE 2, REF A60 SP002, STERILE R, Rx only. Interphalangeal implant
Creator: In2Bones, SAS
Published: 2015-03-09
License: https://open.fda.gov/license/

In2Bones SAS / initiated 2015-03-09 / Terminated / root cause: manufacturing process

FDA source

In2Bones, SAS began a recall of DUAFIT(R) PIP 0o CA SIZE 2, REF A60 SP002, STERILE R, Rx only. Interphalangeal implant on 2015-03-09. FDA classified it as Class II and gives the reason as "Dimensional non-conformity leading to the impossibility to introduce the implant in the dedicated holder". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1318-2015
Classification: Class II
Status: Terminated
Initiated: 2015-03-09
Posted: 2015-03-25
Terminated: 2016-05-19
Recalling firm: In2Bones SAS
Product: DUAFIT(R) PIP 0o CA SIZE 2, REF A60 SP002, STERILE R, Rx only. Interphalangeal implant.
Product code: HWC Screw, Fixation, Bone
Reason for recall: Dimensional non-conformity leading to the impossibility to introduce the implant in the dedicated holder.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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.
Quantity in commerce: 35 units
Distribution: Distributed in the state of TN.
Product codes and lots: Batch numbers: 1404032, 1412011

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1318-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1318-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-01	2015-03-25
Z-1319-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-01	2015-03-25

Product code HWC

K132912Class IIDuafit Intergphalangeal Implant, Peek-Fuse Interphalangeal ImplantIn2bones Sas / cleared 2014-07-30

China's FDA-registered implant bench is 151 establishments of 4,70415 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)