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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 64313

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

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Event summary

Timeline bucket
December 27, 2012
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Stryker Spine

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

Stryker XIA 3 Iliac Screwdriver, 3-PCS. The XIA 3 Iliac Screwdriver is used to drive XIA 3 closed head Monoaxial and closed head Polyaxial screws into the Ilium. Orthopedic manual surgical instrument.

Z-0893-2013
Recall number
Z-0893-2013
Initiated
December 27, 2012
Classification
Class II
Status
Terminated
Recalling firm
Stryker Spine
Quantity
46 units US

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Surgeons have experienced unthreading of the screwdrivers outer shafts during use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Surgeons have experienced unthreading of the screwdrivers outer shafts during use.

Code information

Catalog Number: 48231326. Lot Number: 10G637; 10G638 and 10E852.

Distribution pattern

Nationwide Distribution including the states of AL, AZ, CA, CO, FL, GA, IA, IL,IN, KS, LA, MA, MD, MI, MO, MN, NC, NY. OH, OK, OR, PA, TN, TX, UT and WI.