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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 71740

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
July 20, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
TITAN SPINE, LLC

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

1 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 1

Titan Spine Endoskeleton Locking Bone Screw Assembly, which is part of the Endoskeleton TCS Interbody Fusion Device, spinal implant. Part Numbers / Product Description: 5302-3514 / 03.5 x 14mm Locking Screws; 5302-3516 / 03.5 x 16mm Locking Screws; 502-3518 / 03.5 x 18mm Locking Screws; 5302-3814 / 03.8 x 14mm Locking Screws; 5302-3816 / 03.8 x 16 mm Locking Screws; 5302-3818 / 03.8 x 18mm Locking Screws.

Z-2327-2015
Recall number
Z-2327-2015
Initiated
July 20, 2015
Classification
Class II
Status
Terminated
Recalling firm
TITAN SPINE, LLC
Quantity
137 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Titan Spine is recalling specific Endoskeleton TCS Integrated Locking Bone Screw Assembly due to the locking bone screw collars not 'locking'.

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

Titan Spine is recalling specific Endoskeleton TCS Integrated Locking Bone Screw Assembly due to the locking bone screw collars not 'locking'.

Code information

Lot numbers: V03, V05, V06

Distribution pattern

Distributed in the states of CA, TX, OK, MA, NY, IN, OR, and GA.