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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 75889

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

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Event summary

Timeline bucket
December 02, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Stryker Howmedica Osteonics Corp.

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

Reunion TSA Peg Alignment Sound Catalog #5901-1038 The Peg Alignment Sound (PIN 5901-1038, Revision A) is an instrument used in the ReUnion TSA shoulder system for confirming seating height and peg alignment of the TSA Self-Pressurizing Polyethylene Glenoid implant prior to final implantation into the glenoid vault. Its purpose is to provide assurance that the drilled holes for seating of the Glenoid implant have been properly prepared using the provided instrumentation

Z-1020-2017
Recall number
Z-1020-2017
Initiated
December 02, 2016
Classification
Class II
Status
Terminated
Quantity
131 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Reunion TSA Peg Alignment Sound broke during surgery.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

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Inspect official wording and provenance

Reason for recall

Reunion TSA Peg Alignment Sound broke during surgery.

Code information

Catalog #5901-1038

Distribution pattern

Nationwide Distribution