Reported Jul 8, 2015 · Terminated
Bullet-Tip PEEK VBR/IBF System, 32mm(l) 13mm(H) Implant 32-13-32 UDI (01)008464680341 08(17)191218(10)200827; T-Plus…
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) · 375 River Park Cir · Marquette, MI · 49855-1781
Is this the product you have?
3 of 3 products
| # | Barcodes | Product as published |
|---|---|---|
| 1 | 008464680341 | Bullet-Tip PEEK VBR/IBF System, 32mm(l) 13mm(H) Implant 32-13-32 UDI (01)008464680341 08(17)191218(10)200827 |
| 2 | 00846468032920 | 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 |
| 3 | 00846468032760 | 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. |
- Lot codes and dates
- Part Number32-13-32
- Lot200827
- Expiration Date2019-12-18
- Part Number30-T-13-6
- Lot202726
- Expiration Date2020-01-16
- Part Number30-T-1036-13-6
- Lot202582
- Expiration Date2020-01-15
- Amount recalled
- 18
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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