Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Bullet-Tip PEEK VBR/IBF System Recalled by RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) Due to Mislabeling
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) directly.
Affected Products
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.
Quantity: 18
Why Was This 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.
Where Was This Sold?
This product was distributed to 2 states: FL, NY
About RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) has 50 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report