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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 70736

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
March 09, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
In2Bones, SAS

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

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

Z-1318-2015
Recall number
Z-1318-2015
Initiated
March 09, 2015
Classification
Class II
Status
Terminated
Recalling firm
In2Bones, SAS
Quantity
35 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Dimensional non-conformity leading to the impossibility to introduce the implant in the dedicated holder.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Batch numbers: 1404032, 1412011

Distribution pattern

Distributed in the state of TN.

device · product 2 of 2

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

Z-1319-2015
Recall number
Z-1319-2015
Initiated
March 09, 2015
Classification
Class II
Status
Terminated
Recalling firm
In2Bones, SAS
Quantity
15 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Dimensional non-conformity leading to the impossibility to introduce the implant in the dedicated holder.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Batch numbers: 1412021

Distribution pattern

Distributed in the state of TN.