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Synthes (USA) Products LLC recalls VEPTR Vertical Expandable Prosthetic Titanium Rib, inferior cradles also known as caudal rib supports. The VEPTR/VEPTR
Recalled September 9, 2015 · FDA recall Z-2488-2015 · Synthes (USA) Products
Hazard
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. · FDA Class II
Units
3262
Sold at
Worldwide distribution including US nationwide, Canada and Germany.
Description
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.
Product
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.
Manufacturer(s)
Synthes (USA) Products LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →