CLASS II Device recall · Reported 26 Oct 2016 · FDA Enforcement Report
RTI Surgical Streamline OCT Occipito-Cervico-Thoracic recalled
RTI Surgical, Inc. ( is recalling RTI Surgical Streamline OCT Occipito-Cervico-Thoracic Spinal Rod, CoCr (D) (L), distributed nationwide in the US. The recall was initiated on 16 Sep 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0290-2017
- FDA event ID
- 75242
- Recalling firm
- RTI Surgical, Inc. (, Marquette, MI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Sep 2016
- FDA classified
- 19 Oct 2016
- Reported
- 26 Oct 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Lead & Heavy Metals
- Device type
- Spinal Implants
Timeline
| 16 Sep 2016 | Recall initiated by company | |
| 19 Oct 2016 | Classified by FDA | +33 days |
| 26 Oct 2016 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
RTI Surgical Inc. (RTI) is conducting a voluntary recall on two specific lots of the Streamline¿ OCT Straight Rod, CoCr. 3.2mm (D) x 240mm (L) due to the potential for small cracks to be present on the rods. The small cracks on the rods used in implants could cause reduced strength of these affected implants, and lead to patient injury.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
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 intended for: degenerative disc disease (as defined by neck or back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture/ dislocation, atlanto/axial fracture with instability, occipito-cervical dislocation, deformities or curvature, tumors, pseudoarthrosis, and revision of previous cervical and upper thoracic spine surgery. The occipital bone screws are limited to occipital fixation only. The use of the pedicle screws (standard and high angle) is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. The pedicle screws are not intended for use in the cervical spine. The hooks, connectors, and rods are also intended to provide stabilization to promote fusion following reduction of fracture/ dislocation or trauma in the cervical/ upper thoracic (C1-T3) spine.
Where it was distributed
US Nationwide Distribution in the states of: AL, CA, CO, FL, IN, IL, MI, MO, MS, NC, NY, OK, TN, TX, and VA,.
Nationwide AlabamaCaliforniaColoradoFloridaIllinoisIndianaMichiganMissouriMississippiNorth CarolinaNew YorkOklahomaTennesseeTexasVirginia
Questions about this recall
Is RTI Surgical Streamline OCT Occipito-Cervico-Thoracic Spinal Rod, CoCr (D) (L) recalled?
Yes. RTI Surgical, Inc. ( recalled RTI Surgical Streamline OCT Occipito-Cervico-Thoracic Spinal Rod, CoCr (D) (L) on 16 Sep 2016. The recall is Class II and its status is Terminated. Recall number Z-0290-2017.
Why was it recalled?
RTI Surgical Inc. (RTI) is conducting a voluntary recall on two specific lots of the Streamline¿ OCT Straight Rod, CoCr. 3.2mm (D) x 240mm (L) due to the potential for small cracks to be present on the rods. The small cracks on the rods used in implants could cause reduced strength of these affected implants, and lead to patient injury.
Which lots are affected?
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
Where was it sold?
US Nationwide Distribution in the states of: AL, CA, CO, FL, IN, IL, MI, MO, MS, NC, NY, OK, TN, TX, and VA,.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from RTI Surgical, Inc. (
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|---|---|---|---|---|---|
| Device | CLASS II | CervAlign Anterior Cervical Plate System-Cervalign recalled | RTI Surgical, Inc. ( | Other | Nationwide |
| Device | CLASS II | CervAlign Anterior Cervical Plate System-Cervalign recalled | RTI Surgical, Inc. ( | Other | Nationwide |
| Device | CLASS II | CervAlign Anterior Cervical Plate System-Cervalign recalled | RTI Surgical, Inc. ( | Other | Nationwide |
| Device | CLASS II | CervAlign Anterior Cervical Plate System-Cervalign recalled | RTI Surgical, Inc. ( | Other | Nationwide |
| Device | CLASS II | CervAlign Anterior Cervical Plate System-Cervalign recalled | RTI Surgical, Inc. ( | Other | Nationwide |
Other Spinal Implants recalls
All 1,157| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: ENT recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: A-P PACK recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |