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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 92520

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
June 12, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
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

2 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 2

AEQUALIS FLEX REVIVE Assembly Screw 0mm, Model Number ARS655101

Z-2019-2023
Recall number
Z-2019-2023
Initiated
June 12, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Tornier, Inc
Quantity
55 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A comingle/swap resulted in the labeling and laser marking on the product to state it is a Aequalis Flex Revive Assembly Screw 0mm Standard (ARS655101) but it was a Aequalis Flex Revive Assembly Screw 0mm Short (ARS655118) & vice versa.

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

A comingle/swap resulted in the labeling and laser marking on the product to state it is a Aequalis Flex Revive Assembly Screw 0mm Standard (ARS655101) but it was a Aequalis Flex Revive Assembly Screw 0mm Short (ARS655118) & vice versa.

Code information

GTIN 00846832069408, Serial Numbers: AZ1822082001, AZ1822082002, AZ1822082003, AZ1822082004, AZ1822082005, AZ1822082006, AZ1822082007, AZ1822082008, AZ1822082009, AZ1822082010, AZ1822082011, AZ1822082012, AZ1822082013, AZ1822082014, AZ1822082015, AZ1822082016, AZ1822082017, AZ1822082018, AZ1822082019, AZ1822082020, AZ1822082021, AZ1822082022, AZ1822082023, AZ1822082024, AZ1822082025, AZ1822082026, AZ1822082027, AZ1822082028, AZ1822082029, AZ1822082030, AZ1822082031, AZ1822082032, AZ1822082033, AZ1822082034, AZ1822082035, AZ1822082036, AZ1822082037, AZ1822082038, AZ1822082039, AZ1822082040, AZ1822082041, AZ1822082042, AZ1822082043, AZ1822082044, AZ1822082045, AZ1822082046, AZ1822082047, AZ1822082048, AZ1822082049, AZ1822082050, AZ1822082051, AZ1822082052, AZ1822082053, AZ1822082054, AZ1822082055

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Australia, Canada, Netherlands, Spain, United Kingdom.

device · product 2 of 2

AEQUALIS FLEX REVIVE Assembly Screw 0mm Short, Model Number ARS655118

Z-2020-2023
Recall number
Z-2020-2023
Initiated
June 12, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Tornier, Inc
Quantity
55 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A comingle/swap resulted in the labeling and laser marking on the product to state it is a Aequalis Flex Revive Assembly Screw 0mm Standard (ARS655101) but it was a Aequalis Flex Revive Assembly Screw 0mm Short (ARS655118) & vice versa.

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

A comingle/swap resulted in the labeling and laser marking on the product to state it is a Aequalis Flex Revive Assembly Screw 0mm Standard (ARS655101) but it was a Aequalis Flex Revive Assembly Screw 0mm Short (ARS655118) & vice versa.

Code information

GTIN 00846832069408, Serial Numbers: AZ1322077001, AZ1322077002, AZ1322077003, AZ1322077004, AZ1322077005, AZ1322077006, AZ1322077007, AZ1322077008, AZ1322077009, AZ1322077010, AZ1322077011, AZ1322077012, AZ1322077013, AZ1322077014, AZ1322077015, AZ1322077016, AZ1322077017, AZ1322077018, AZ1322077019, AZ1322077020, AZ1322077021, AZ1322077022, AZ1322077023, AZ1322077024, AZ1322077025, AZ1322077026, AZ1322077027, AZ1322077028, AZ1322077029, AZ1322077030, AZ1322077031, AZ1322077032, AZ1322077033, AZ1322077034, AZ1322077035, AZ1322077036, AZ1322077037, AZ1322077038, AZ1322077039, AZ1322077040, AZ1322077041, AZ1322077042, AZ1322077043, AZ1322077044, AZ1322077045, AZ1322077046, AZ1322077047, AZ1322077048, AZ1322077049, AZ1322077050, AZ1322077051, AZ1322077052, AZ1322077053, AZ1322077054, AZ1322077055

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Australia, Canada, Netherlands, Spain, United Kingdom.