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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 79613

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

Open FDA event record

Event summary

Timeline bucket
February 21, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Allen Medical Systems

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

F-T3SYSTEM, T3 (Trumpf Table Top) System The device is a surgical table accessory system used to allow prone positioning on OR table tops during spinal surgery. The system consists of a table top frame, arm supports,

Z-1262-2018
Recall number
Z-1262-2018
Initiated
February 21, 2018
Classification
Class II
Status
Terminated
Recalling firm
Allen Medical Systems
Quantity
83

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The recalling firm has become aware that the rail section clamps used to attach the leg support of the device may fail during use, which could result in critical harm to the patient.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The recalling firm has become aware that the rail section clamps used to attach the leg support of the device may fail during use, which could result in critical harm to the patient.

Code information

Serial Numbers: A166677 A201568 A311424 A333604 A353171 A385408 A166678 A201569 A311425 A339446 A357145 A385409 A170724 A201570 A314187 A339447 A359864 A385410 A179337 A209110 A319402 A348001 A362219 A386775 A182027 A209111 A320583 A348174 A364982 A386776 A183578 A209112 A320584 A348175 A369558 A386777 A188535 A209113 A322480 A348176 A369884 A386778 A194789 A282259 A322597 A348177 A370262 A390698 A194790 A282260 A325663 A348178 A372387 A390699 A197337 A282537 A325664 A348179 A378593 A390700 A197338 A282538 A326358 A352174 A378594 A390701 A197339 A309460 A331161 A352175 A378595 A390702 A197554 A309461 A331162 A352176 A378596 A390703 A198334 A309462 A331163 A352177 A378597 A395121 A198335 A309463 A333601 A353168 A384029 A395122 A198336 A309464 A333602 A353169 A384329 A395123 A201567 A309465 A333603 A353170 A384330

Distribution pattern

Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Australia, France, Saudi Arabia, Germany, and France.