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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93840

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

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Event summary

Timeline bucket
December 21, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Medagent 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

Rebstock Holding rod for fixation -For holding and fixation of flexible Leyla Arms and spatula Art. No. 06-06-285 and 06-06-285MOD. surgical instrument.

Z-1184-2024
Recall number
Z-1184-2024
Initiated
December 21, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Medagent Inc
Quantity
84 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Holding arm could move (twist) uncontrollably in the front area. This could lead to a serious deterioration of patient's safety if the movement is transferred to the spatula, which is attached to the holding arm.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Holding arm could move (twist) uncontrollably in the front area. This could lead to a serious deterioration of patient's safety if the movement is transferred to the spatula, which is attached to the holding arm.

Code information

Batches: 6221672, 6222079, 6230282, 6230985, 6230986, 6231808, 6222559, 6231989, 6221673

Distribution pattern

TX Foreign: Algeria China Dominican Republic Germany India Japan Philippines UK