Recall Z-1916-2015— RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

Name: FDA recall Z-1916-2015
Creator: U.S. Food and Drug Administration
Published: 2015-05-21

Class II · Terminated

Class II FDA medical device recall by RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.), initiated 2015-05-21, terminated 2015-10-29. It names one FDA 510(k) clearance: K133455. Product: 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.. Reason: 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..

Recalling firm: RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Classification: Class II
Status: Terminated
Initiated: 2015-05-21
Terminated: 2015-10-29
Firm location: Marquette, MI, United States

510(k) clearances named in this recall

1 on FDA's record

K133455 — CROSSFUSE II CORONAL TAPER, CROSSFUSE II HYPERLORDOTICPioneer Surgical Technology, Inc.·cleared 2014-03-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.