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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 70576

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

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Event summary

Timeline bucket
February 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

Endo TCS Driver Straight Hexalobe #6 P/N 5210-1004, Non-Sterile, Manufactured by Titan Spine, LLC. Endo TCS driver is one of the instruments within the surgical tray for use with the Interbody Fusion Device(IBD).

Z-1324-2015
Recall number
Z-1324-2015
Initiated
February 20, 2015
Classification
Class II
Status
Terminated
Recalling firm
TITAN SPINE, LLC
Quantity
26

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The TCS Straight Hexlobular #6 Drivers (5210-1004) tip sheared off during use in procedures that involved patients with dense bones. As a result of this malfunction, Titan Spine, LLC is removing all of the TCS Straight Hex lobular #6 Drivers (5210-1004) Lot# G150101 from the field.

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

The TCS Straight Hexlobular #6 Drivers (5210-1004) tip sheared off during use in procedures that involved patients with dense bones. As a result of this malfunction, Titan Spine, LLC is removing all of the TCS Straight Hex lobular #6 Drivers (5210-1004) Lot# G150101 from the field.

Code information

G150101

Distribution pattern

US Distribution to the states of : AZ, CA, CT, FL, GA, ID, IL, KY, MD, MO, NV, NY, OH, OK, OR, TX, UT and WI.