RTI Surgical Recalls Streamline OCT Navigated Instruments Due to Missing Drill Guide
RTI Surgical is recalling 76 units of Streamline OCT Navigated Instruments because the system does not include a drill guide. The devices were distributed to one distributor in Michigan.
What this means for you
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: The recall is classified as FDA Class II. The source text does not report any injuries, illnesses, or hospitalizations, and the hazard is a missing component (drill guide) rather than a high-risk pathogen or structural defect causing immediate harm. This aligns with the 'Moderate' criteria for voluntary precautionary recalls or minor labeling/component errors without reported harm.
Plain-English summary
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) is recalling 76 units of Streamline OCT Navigated Instruments. The affected catalog numbers are 26-DRILL-MDN, 26-FTAP-30-MDN, 26-FTAP-35-MDN, 26-FTAP-40-MDN, 26-FTAP-45-MDN, and 26-S-FINDER-MDN. These instruments are components of a surgical navigation device.
The recall was initiated because the system does not include a drill guide. The affected units were distributed to one distributor in Michigan. The specific lot numbers involved are 370855, 373847, 373848, 373849, 377629, 373850, and 373846.
Healthcare providers and distributors should stop using the affected instruments and contact RTI Surgical for instructions on return or replacement. This recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Streamline OCT Navigated Instruments, Catalog numbers 26-DRILL-MDN 26-FTAP-30-MDN 26-FTAP-35-MDN 26-FTAP-40-MDN 26-FTAP-40-MDN 26-FTAP-45-MDN 26-S-FINDER-MDN Components of a surgical navigation device.
- Hazard
- Affected units
- 76
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 (1)
- Lots 370855 373847 373848 373849 377629 373850 373846
Distribution
Distributed in 1 state:
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