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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90526

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

Open FDA event record

Event summary

Timeline bucket
November 18, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
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

ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R

Z-1429-2022
Recall number
Z-1429-2022
Initiated
November 18, 2020
Classification
Class II
Status
Terminated
Quantity
17

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Fracture or breakage of the spinal fixation arm at the downtube instrument if the 90 degree angle is not met when using the removal key with the spinal fixation system. Redesign of removal key.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Fracture or breakage of the spinal fixation arm at the downtube instrument if the 90 degree angle is not met when using the removal key with the spinal fixation system. Redesign of removal key.

Code information

UDI-DI: 04046964719622

Distribution pattern

United States Nationwide distribution in the states of CA, CO, MI, NH, OH, SC & TX.