RTI Surgical Streamline OCT Final Driver Recalled for Fracture Risk
RTI Surgical is recalling Streamline OCT Final Drivers due to reduced mechanical strength that may cause the tip to fracture during use.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect (fracturing) in a medical device used during surgery, which aligns with the rubric criteria for Severe severity involving significant injury risk or structural defects.
Plain-English summary
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) is recalling multiple lots of the RTI Surgical Streamline Occipito-Cervico-Thoracic (OCT) Final Driver, commonly known as a screw driver. The recall involves product code 26-FNLDRIVER and specific lot numbers including 177091, 177093, 183817, 207727, 223926, 227291, 229134, 230523, 232262, 233074, and 234205.
The recall was initiated because the devices may have reduced mechanical strength, which can result in the driver tip fracturing during use. This is a Class II recall, indicating that use of the product could cause temporary or medically reversible health consequences.
The affected products were distributed domestically in Alabama, Colorado, Connecticut, Florida, Indiana, Idaho, Illinois, Michigan, Mississippi, Missouri, North Carolina, New York, and Texas. No foreign or VA/DOD distribution is reported. Healthcare facilities and users should stop using the affected devices and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- RTI Surgical Streamline Occipito-Cervico-Thoracic (OCT) Final Driver, Common Name: Screw Driver
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (12)
- 26-FNLDRIVER
- Lot Numbers: 177091
- 177093
- 183817
- 207727
- 223926
- 227291
- 229134
- 230523
- 232262
- 233074
- 234205
Distribution
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