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U.S. Department of Health and Human Services

Class 2 Device Recall Rotate, BulletTip, TPlus, Contact, Crossfuse, and CrossFuse II, Interbody Fusion/Vertebral Body Re

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  Class 2 Device Recall Rotate, BulletTip, TPlus, Contact, Crossfuse, and CrossFuse II, Interbody Fusion/Vertebral Body Re see related information
Date Initiated by Firm May 21, 2015
Date Posted June 26, 2015
Recall Status1 Terminated 3 on October 29, 2015
Recall Number Z-1916-2015
Recall Event ID 71424
510(K)Number K133455  
Product Classification Intervertebral fusion device with bone graft, lumbar - Product Code MAX
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.
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
Recalling Firm/
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
375 River Park Cir
Marquette MI 49855-1781
For Additional Information Contact Dan Nelson
Manufacturer 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.
FDA Determined
Cause 2
Error in labeling
Action RTI Surgical sent an" Urgent Medical Device Voluntary Recall " Notification dated May 21, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Immediate Actions: We are aware that one of this product was distributed to you. This one device has already been returned to RTI Surgical so no further action is needed. This notice is for your records. RTI takes this error seriously and has initiated a corrective and preventative action investigation to prevent recurrence. We apologize for any inconvenience this may have caused. For further questions please call (906) 226-4489.
Quantity in Commerce 18
Distribution US Distribution to the states of : FL and NY
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MAX and Original Applicant = PIONEER SURGICAL TECHNOLOGY, INC