Data Foundry

Medical device recalls 2018

F-T3SYSTEM — Class II medical device recall Z-1262-2018

Terminated recall by Allen Medical Systems, reported 2018-04-04, distributed nationwide. The recalling firm has become aware that the rail section clamps used to attach the leg support of the device

Recall numberZ-1262-2018
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmAllen Medical Systems, Acton, MA, United States
Recall initiated2018-02-21
Classified2018-03-28
Reported by FDA2018-04-04
Terminated2020-04-06
DistributedNationwide (US)
Countries outside the USAU, DE, FR, SA
Quantity83
Reason classesdevice malfunction
Serial numbersA166677, A166678, A170724, A179337, A182027, A183578, A188535, A194789, A194790, A197337, A197338, A197339, A197554, A198334, A198335, A198336, A201567, A201568, A201569, A201570, A209110, A209111, A209112, A209113, A282259 and 76 more

Product

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,

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1262-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.