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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84045

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

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Event summary

Timeline bucket
December 06, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Medtronic Navigation, 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.

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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

Medtronic Adapter Percutaneous Pin, REF 9734752 (GTIN 00643169529489) and REF 9734752-G02 (GTIN 00763000054915), contained in the following kits: Upgrade Set Percutaneous Pin, REF 9735502 (GTIN 00643169529533) and REF 9735502-G02 (GTIN 00763000208462); Medtronic Adapter Percutaneous Pin Kit, REF 9734752K (GTIN 00643169540521); and Medtronic Adapter Percutaneous Pin Kit, REF 9734752K (GTIN 00643169641006) (Japan). The percutaneous pin adapter is a component of the StealthAir Frame Assembly.

Z-0707-2020
Recall number
Z-0707-2020
Initiated
December 06, 2018
Classification
Class II
Status
Terminated
Quantity
1,297 percutaneous pin adapters

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Under certain circumstances, the percutaneous pin adapter used with the StealthAir Frame Assembly may slightly rotate after surgical placement and not return to its original position, even when connections are tight and secure.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

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Reason for recall

Under certain circumstances, the percutaneous pin adapter used with the StealthAir Frame Assembly may slightly rotate after surgical placement and not return to its original position, even when connections are tight and secure.

Code information

Percutaneous pin adapter lot numbers: 150114, 150505, 150506, 150904, 151005, 151007 160201, 160224, 160419, 160617, 160707, 170216, 180110, and 180409.

Distribution pattern

Distribution was nationwide. There was government/military/foreign distribution.

Field note

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