Bullet-Tip PEEK VBR/IBF System recalled over labeling errors

Recall date

May 21, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) recalls Bullet-Tip PEEK VBR/IBF System, 32mm(l) 13mm(H) Implant 32-13-32 UDI (01)008464680341 08(17)191218(10)200827; T-Plus PE…

Recall number

Z-1916-2015

FDA classification

Class II

Brand / firm

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

Sold / distributed

US Distribution to the states of : FL and NY

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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(l) x 13mm(H) Implant, 6degree lordotic 30-T-1036-13-6 UDI (01)00846468032760(17)200115(10)202582. These products are part of the lnterbody Fusion Vertebral Body Replacement System to ensure stability of the spine and adequate compression of the implant.