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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84383

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
January 25, 2019
Product types
Device
Classifications
Class III
Statuses
Terminated
Recalling firm wording
AAP Implantate Ag

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

2 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 2

INTEGRA, Drill CS 4.5, quick coupling single use, REF 430453

Z-0731-2020
Recall number
Z-0731-2020
Initiated
January 25, 2019
Classification
Class III
Status
Terminated
Recalling firm
AAP Implantate Ag
Quantity
2 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Products were distributed with the incorrect instructions for use.

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

Products were distributed with the incorrect instructions for use.

Code information

Lot Code: QR0013

Distribution pattern

Texas

device · product 2 of 2

INTEGRA, Drill CS 4.0, quick coupling single use, REF 430425

Z-0732-2020
Recall number
Z-0732-2020
Initiated
January 25, 2019
Classification
Class III
Status
Terminated
Recalling firm
AAP Implantate Ag
Quantity
7 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Products were distributed with the incorrect instructions for use.

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

Products were distributed with the incorrect instructions for use.

Code information

Lot Code: QS0007

Distribution pattern

Texas

Field note

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