Bullet-Tip PEEK VBR/IBF System — Class II medical device recall Z-1916-2015
Terminated recall by RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.), reported 2015-07-08, distributed in FL, NY. Three lots of the Bullet -Tip VBR 13mm x 32 mm implants are mislabeled with a light green colored label, used
| Recall number | Z-1916-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.), Marquette, MI, United States |
| Recall initiated | 2015-05-21 |
| Classified | 2015-06-26 |
| Reported by FDA | 2015-07-08 |
| Terminated | 2015-10-29 |
| Distributed | FL, NY |
| Quantity | 18 |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00846468032760, 00846468032920 |
| Lot numbers | 200827, 202582, 202726 |
| Model numbers | 30-T-1036-13-6, 30-T-13-6, 32-13-32 |
| Expiration dates | 2019-12-18, 2020-01-15, 2020-01-16 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1916-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.