Z-1916-2015Class II

Bullet-Tip PEEK VBR/IBF System, 32mm(l) 13mm(H) Implant 32-13-32 UDI (01)008464680341 08(17)191218(10)200827...

Name: Z-1916-2015 Bullet-Tip PEEK VBR/IBF System, 32mm(l) 13mm(H) Implant 32-13-32 UDI (01)008464680341 08(17)191218(10)200827...
Creator: RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Published: 2015-05-21
License: https://open.fda.gov/license/

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) / initiated 2015-05-21 / Terminated / root cause: labeling and UDI

FDA source

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) began a recall of 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... on 2015-05-21. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1916-2015
Classification: Class II
Status: Terminated
Initiated: 2015-05-21
Posted: 2015-06-26
Terminated: 2015-10-29
Recalling firm: RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
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.
Product code: MAX Intervertebral Fusion Device With Bone Graft, Lumbar
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.
Root cause tag: labeling and UDI
FDA 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 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1916-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1916-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-08	2015-06-26

Product code MAX

K133455Class IICrossfuse II Coronal Taper, Crossfuse II HyperlordoticPioneer Surgical Technology, Inc. / cleared 2014-03-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)