Recall Z-1916-2015 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
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.
| Date | Jun 26, 2015 (initiated May 21, 2015) |
| Status | Terminated |
| 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. |
| Root cause | 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 |
| Quantity | 18 |
| Distribution | US Distribution to the states of : FL and NY |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133455 | CROSSFUSE II CORONAL TAPER, CROSSFUSE II HYPERLORDOTIC Pioneer Surgical Technology, Inc., Mar 27, 2014 |