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.
FDA Recall Z-1916-2015 · Posted 2015-06-26
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Recall StatusTerminated
Product CodeMAX
Date Initiated2015-05-21
Date Terminated2015-10-29
Product Quantity18
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.
Firm 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.
Root Cause
Error in labeling
Distribution Pattern
US Distribution to the states of : FL and NY
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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