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Terminated

VEPTR Vertical Expandable Prosthetic Titanium Rib, inferior cradles also known as caudal rib supports. The VEPTR/VEPTR II devices mechanically stabilize and/or correct thoracic deformities to allow the chest and lungs to grow.

FDA Recall Z-2488-2015 · Posted 2015-08-31

Recalling FirmSynthes (USA) Products LLC
Recall StatusTerminated
Product CodeMDI
Date Initiated2015-07-29
Date Terminated2016-08-18
Product Quantity3262

Reason for Recall

The last hole on certain VEPTR Inferior Cradles may be partially formed. Fully lengthening the construct to the partially formed last hole may result in mechanical failure of the construct due to rib sleeve breakage, and may require surgury to exchange components. Effects may also include pain, loss of deformity correction, and/or soft tissue/visceral injury.

Firm Action

Urgent recall letters, dated July 29, 2015, were sent to end users alerting them to the problem, the associated risk to patients, and provided instruction to return affected devices withthe response form.

Root Cause

Process control

Distribution Pattern

Worldwide distribution including US nationwide, Canada and Germany.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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