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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93979

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

Open FDA event record

Event summary

Timeline bucket
January 29, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Waldemar Link GmbH & Co. KG (Mfg Site)

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

Embrace Drill Tower, Wedged (25mm)

Z-1257-2024
Recall number
Z-1257-2024
Initiated
January 29, 2024
Classification
Class II
Status
Ongoing
Quantity
6 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The surgical techniques for the Embrace Shoulder Instruments -Drill Tower (Article REF 645-081/62 & /63) have mixed-up type descriptions ("standard" vs "wedged") in the overview of the instruments.

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

The surgical techniques for the Embrace Shoulder Instruments -Drill Tower (Article REF 645-081/62 & /63) have mixed-up type descriptions ("standard" vs "wedged") in the overview of the instruments.

Code information

Item Number: 645-081/62; UDI/DI: 04026575534715; All lots of the LINK Embrace Drill Tower surgical instruments.

Distribution pattern

US Nationwide distribution in the states of AL and LA.

device · product 2 of 2

Embrace Drill Tower, Standard/Lateral (25mm)

Z-1258-2024
Recall number
Z-1258-2024
Initiated
January 29, 2024
Classification
Class II
Status
Ongoing
Quantity
6 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The surgical techniques for the Embrace Shoulder Instruments -Drill Tower (Article REF 645-081/62 & /63) have mixed-up type descriptions ("standard" vs "wedged") in the overview of the instruments.

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

The surgical techniques for the Embrace Shoulder Instruments -Drill Tower (Article REF 645-081/62 & /63) have mixed-up type descriptions ("standard" vs "wedged") in the overview of the instruments.

Code information

Item Number: 645-081/63; UDI/DI: 04026575534722; All lots of the LINK Embrace Drill Tower surgical instruments.

Distribution pattern

US Nationwide distribution in the states of AL and LA.