The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-0290-2017·Announced 2016-10-26

RTI Surgical Recalls Streamline OCT Spinal Rods Due to Cracks

RTI Surgical is voluntarily recalling 66 units of Streamline OCT spinal rods due to potential cracks that could reduce strength and cause patient injury.

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 in a spinal implant that could lead to patient injury, meeting the criteria for a Severe rating.

Plain-English summary

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) is conducting a voluntary recall of 66 units of the Streamline OCT Straight Rod, CoCr, 3.2mm (D) x 240mm (L). The recall involves two specific lots: Lot 234829 and Lot 246678.

The recall is being conducted due to the potential for small cracks to be present on the rods. These cracks could cause reduced strength in the affected implants, which may lead to patient injury. The product is intended to promote fusion of the cervical spine and occipitocervico-thoracic junction.

The affected units were distributed nationwide in the states of Alabama, California, Colorado, Florida, Indiana, Illinois, Michigan, Missouri, Mississippi, North Carolina, New York, Oklahoma, Tennessee, Texas, and Virginia. Patients who have had this specific implant should contact their healthcare provider for evaluation.

The recalled product

Product
RTI Surgical Streamline OCT Occipito-Cervico-Thoracic Spinal Rod, CoCr, 3.2mm (D) x 240mm (L) Product Usage: When intended to promote fusion of the cervical spine and occipitocervico-thoracic junction (occiput-T3), the Streamline OCT Occipito-Cervico-Thoracic System is…
Manufacturer
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Category
Medical Device — Spinal Implant
Hazard
Affected units
66

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 (5)

  • Part Number: 23-CC-ROD-240
  • Lot Number: 234829
  • UDI Number: (01)0084646802 7179( 10}234829
  • Lot Number: 246678
  • UDI Number: {01}00846468027179{10}246678

Distribution

Distributed nationwide across the United States.

The notice also names 15 states specifically:

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