Exact FDA event identifier

Event 73657

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

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Event summary

Timeline bucket: July 26, 2013
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Atlas Spine, Inc.

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

Atlas Spine Torque Limiting Handle 6N-m, P/N 70089 Model # ITN-001-000 Used to rotate implant into position

Z-1616-2016

Recall number: Z-1616-2016
Initiated: July 26, 2013
Classification: Class II
Status: Terminated
Recalling firm: Atlas Spine, Inc.
Quantity: 16

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The device was not appropriately set to mitigate the risk of implant fracture upon rotation inside the disc space.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

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Inspect official wording and provenance

Reason for recall

The device was not appropriately set to mitigate the risk of implant fracture upon rotation inside the disc space.

Code information

Lots #: 8887, 000073, 000135, 00434, and 02518.

Distribution pattern

Nationwide Distribution to FL, MO, and WV.