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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 87842

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

Open FDA event record

Event summary

Timeline bucket
April 27, 2021
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Medtronic Sofamor Danek USA, 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.

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

Braive Growth Modulation System Break-Off Set Screws - Product Usage: intended to limit further progression of the spinal curvature and provide correction of the thoracic curve while allowing continued skeletal growth by compression of the convex side of the scoliotic curve.

Z-1797-2021
Recall number
Z-1797-2021
Initiated
April 27, 2021
Classification
Class II
Status
Terminated
Quantity
162 UNITS

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
defect due to a manufacturing

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

Product is impacted by a thread profile defect due to a manufacturing issue.

Code information

CT20L012 and CT20L020. CT20L012 EXP 2 DEC 2028 CT20L020 EXP 11 DEC 2028

Distribution pattern

International distribution in the countries of France, Switzerland and Jordan. No US distribution.