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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 78997

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

Open FDA event record

Event summary

Timeline bucket
December 20, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Medtronic Neurosurgery

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

Model #: CG8900, Medtronic Clip Gun Scalp Clip Kit (Qty 1); Model #: CG8901, Medtronic Clip Gun Scalp Clip Kit (Qty 10); Model #: CG8901A, Medtronic Clip Gun Applicator (Qty 10)

Z-0622-2018
Recall number
Z-0622-2018
Initiated
December 20, 2017
Classification
Class II
Status
Terminated
Recalling firm
Medtronic Neurosurgery
Quantity
27,432.8 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medtronic is initiating a voluntary recall because the products identified above did not adequately demonstrate acceptable packaging performance to current standards.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medtronic is initiating a voluntary recall because the products identified above did not adequately demonstrate acceptable packaging performance to current standards.

Code information

Affected Lots: D80412, D84100, E00008, E00983, E03049, E03716, E05806, E07257, E09145, E14782, E14896, E15195, E19181, E19182, E19183, E19184, E19868, E20599, E23631, E33102, D80413, D84101, E00009, E00984, E03050, E03717, E05233, E05807, E07258, E09117, E09146, E09239, E11242, E11243, E11244, E11706, E12011, E12012, E13574, E14784, E14898, E15197, E19185, E19186, E19187, E19188, E19869, E20600, E23768, E23769, E23770, E23771, E23772, E23773, E23774, E33103, E33104, E33105, E33106, E33107, E33108, E33109, E33110, E33454, E34928, E05810, E09149, E19194, E19871, E23775, E33099

Distribution pattern

Algeria, Armenia, Australia, Canada, Cyprus, Egypt, Germany, Ghana, Greece, Guam, Iceland, Indonesia, Iran, Italy, Jordan, New Zealand, Poland, Portugal, Puerto Rica, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Swaziland, Sweden, Switzerland, Syria, Tunisia, Turkey, UAE, UK, USA, Yemen

Field note

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