Exact FDA event identifier

Event 65777

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

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Event summary

Timeline bucket: May 30, 2013
Product types: Device
Classifications: Class I
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 Oasys Midline Occiput Plate-1) Small 2) Medium 3) Large 4) Large Long 5) Mini. Allows for positioning directly on the midline keel of the occiput.

Z-1976-2013

Recall number: Z-1976-2013
Initiated: May 30, 2013
Classification: Class I
Status: Terminated
Recalling firm: Stryker Spine
Quantity: 1536 units (US) 880 (Foreign)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Stryker has received reports from customers indicating post-operative fracture of the pin that connects the tulip head to the plate body.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Stryker has received reports from customers indicating post-operative fracture of the pin that connects the tulip head to the plate body.

Code information

K093670 Catalog numbers: Small - 48551044 Medium - 48551045 Large - 48551046 Large Long - 48551047 Mini- 48551048 All lots of the above

Distribution pattern

Nationwide Distribution.