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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 91071

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

Open FDA event record

Event summary

Timeline bucket
August 03, 2022
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Integrity Implants 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

LineSider Spinal System pedicle screws, 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-cannulated. Model Number LS-N6SG6545. Thoracolumbosacral pedicle screw system; Spinal interlaminal fixation orthosis. Product sold as non-sterile and shipped in protective sterilization trays. Screws can also be shipped individually, as tray replenishments. Used in spinal fixation surgery.

Z-0421-2023
Recall number
Z-0421-2023
Initiated
August 03, 2022
Classification
Class II
Status
Terminated
Recalling firm
Integrity Implants Inc.
Quantity
50 screws

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for intraoperative screw head separation at weld location.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for intraoperative screw head separation at weld location.

Code information

Part/Model Number LS-N6SG6545; UDI: (01)00818613027815(10)10210067; Lot Number: 10210067

Distribution pattern

US distribution to California, Indiana, New York, Oklahoma, Washington DC