Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88004

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

Open FDA event record

Event summary

Timeline bucket
May 28, 2021
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Tornier, 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

Aequalis Ascend Flex Shoulder System Reversed Platform (Reversed Tray component) Rx Only Sterile Manufacturer Tornier SAS - Saint Martin, France. Shoulder prosthesis component.

Z-2025-2021
Recall number
Z-2025-2021
Initiated
May 28, 2021
Classification
Class II
Status
Terminated
Recalling firm
Tornier, Inc
Quantity
20

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Two lots have been swapped thus have the incorrect product in the package. The component may be of a different thickness.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Two lots have been swapped thus have the incorrect product in the package. The component may be of a different thickness.

Code information

Item Number DWF500 Lot # 1179AW Exp. Date 2026-02-24 and Item Number DWF510 Lot # 1197AW Exp. Date 2026-02-25

Distribution pattern

IL and TX Belgium, France and United Kingdom