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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90678

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

Open FDA event record

Event summary

Timeline bucket
July 15, 2022
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Aesculap Implant Systems LLC

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

Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental and multisegmental stabilization of the lumbar, thoracic and sacral spine. Article Number: 52758014

Z-1638-2022
Recall number
Z-1638-2022
Initiated
July 15, 2022
Classification
Class II
Status
Ongoing
Quantity
6 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the incorrect screw to be included in the package.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for the incorrect screw to be included in the package.

Code information

GUIDID: 04046964989728 Lot Number: 52758014

Distribution pattern

GA, TX