RTI Surgical Recalls Mislabeled Bullet-Tip PEEK VBR Implants
RTI Surgical is recalling 18 units of three lots of Bullet-Tip PEEK VBR implants distributed in Florida and New York due to incorrect color labeling.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a minor labeling error (incorrect color code for trial size) with no reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) is recalling 18 units of three lots of Bullet-Tip PEEK VBR/IBF System implants. The affected products are part of the Interbody Fusion Vertebral Body Replacement System used to ensure spine stability and adequate compression of the implant.
The recall is due to a labeling error where the implants are mislabeled with a light green colored label, which is used for 16 mm trials, instead of the correct lime green label used for 13 mm trials. The specific affected lots are 200827 (Part Number 32-13-32), 202726 (Part Number 30-T-13-6), and 202582 (Part Number 30-T-1036-13-6).
The products were distributed in the United States to the states of Florida and New York. The source text does not specify the exact actions consumers or healthcare providers should take, nor does it report any illnesses or injuries associated with this labeling error.
The recalled product
- 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…
- Category
- Medical Device — Spinal Implants
- Hazard
- Affected units
- 18
Distribution
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