Exact FDA event identifier

Event 69784

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

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Event summary

Timeline bucket: October 06, 2014
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

Specialty Audible Torque Wrench Mfg by: Stryker Spine, Catalog number IS3002XLP, Non-sterile. Used to final tighten to 12 Nm the blocker of the XIA 3, Hooks, Monoaxial Screws, Rod to Rod Connectors and Off-set connectors.

Z-0803-2015

Recall number: Z-0803-2015
Initiated: October 06, 2014
Classification: Class II
Status: Terminated
Recalling firm: Stryker Spine
Quantity: 15 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Stryker has received a complaint from customers relating to a fracture during the use of the Specialty Audible Torque Wrench in surgery.

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

Stryker has received a complaint from customers relating to a fracture during the use of the Specialty Audible Torque Wrench in surgery.

Code information

Lot number 4279

Distribution pattern

Distributed to GA, IN, MI, NJ, OH, PA, TX & VA.