Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 79093

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

Open FDA event record

Event summary

Timeline bucket
September 21, 2017
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

proSA Tool Set used to adjust and verify the proSA Adjustable Shunt System Shunt, central nervous system and components

Z-0809-2018
Recall number
Z-0809-2018
Initiated
September 21, 2017
Classification
Class II
Status
Terminated
Quantity
2

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A proSA adjusting pin used to adjust the proSA Adjustable Shunt System does not set the correct valve opening pressure.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A proSA adjusting pin used to adjust the proSA Adjustable Shunt System does not set the correct valve opening pressure.

Code information

Batch #20034364 and #20034751

Distribution pattern

US Distribution to PA.