Class II — RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
| Recalling firm | RTI Surgical, Inc. (dba RTI Biologics, Inc.) |
|---|---|
| Registered facility | View this company's 3 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| 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. |
| 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 Replacem… |
| Quantity | 18 |
| Distribution | US Distribution to the states of : FL and NY |
| Initiated | 2015-05-21 |
| Classified | 2015-06-26 |
| Terminated | 2015-10-29 |
| Recall number | Z-1916-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) (Z-1916-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/71424/
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