RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.): Medical Device Recall in 2015 - (Recall #: Z-1916-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: May 21, 2015

Date Posted: July 8, 2015

Recall Number: Z-1916-2015

Event ID: 71424

Reason for Recall:

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.

Status: Terminated

Product Quantity: 18

Code Information:

Part Number: 32-13-32 Lot: 200827 Expiration Date: 2019-12-18 Part Number: 30-T-13-6 Lot: 202726 Expiration Date: 2020-01-16 Part Number: 30-T-1036-13-6 Lot: 202582 Expiration Date: 2020-01-15

Distribution Pattern:

US Distribution to the states of : FL and NY

Voluntary or Mandated:

Voluntary: Firm initiated