Exact FDA event identifier

Event 68863

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

Open FDA event record

Event summary

Timeline bucket: July 11, 2014
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: X Spine Systems 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

Serrated Soft Tissue Shields. Orthopedic surgical instruments, part of the Silex Sacroiliac Fusion System. The soft tissue shields are surgical instrument guides in the Silex Sacroiliac Joint Fusion System for spinal surgery.

Z-2136-2014

Recall number: Z-2136-2014
Initiated: July 11, 2014
Classification: Class II
Status: Terminated
Recalling firm: X Spine Systems Inc
Quantity: A total of 5-pieces of each part number distributed

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Revision B of the tissue shields of the device was 7 mm longer than the previous design.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Revision B of the tissue shields of the device was 7 mm longer than the previous design.

Code information

Part numbers X079-0096 and X079-0097 with Lot #12320

Distribution pattern

US Distribution including the states of FL and MO.