FDAMay 21, 2015device

Bullet-Tip PEEK VBR/IBF System, 32mm(l) 13mm(H) Implant 32-13-32 UDI (01)008464680341 08(17)191218(10)200827; T-Plus PEEK VBR/IBF System, 10mm(W) x 27mm(l) x 13mm(H) Implant, 6degree lordotic 30-T-13-6 UDI (01) 00846468032920(17) 200116(10) 202726; and T-Plus PEEK VBR/IBF System, 10mm(W) x 36 mm(...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Three lots of the Bullet -Tip VBR 13mm x 32 mm implants are mislabeled with a light green colored label, used for 16 mm trial instead of a lime green label, used for a 13 mm trial.

What to do

FDA enforcement status: Terminated

Brands named

rti surgical inc dba pioneer surgical technology incrtirti surgical

UPCs

008464680341080084646803292000846468032760

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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