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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 98987

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

Open FDA event record

Event summary

Timeline bucket
March 24, 2026
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
DT MedTech, 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

Hintermann Series Talar Implant, Left, Size 2 REF 302112

Z-2399-2026
Recall number
Z-2399-2026
Initiated
March 24, 2026
Classification
Class II
Status
Ongoing
Recalling firm
DT MedTech, LLC
Quantity
67 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Through customer complaints, the ankle replacement system was found to contain incorrect devices: Left implant packaging and labeling bears a right implant device.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Through customer complaints, the ankle replacement system was found to contain incorrect devices: Left implant packaging and labeling bears a right implant device.

Code information

Lot: AACAA/ DI: B095302112

Distribution pattern

Worldwide - US Nationwide distribution in the states of CA, AR, AZ, ID and the countries of PER, KOR.