FDASeptember 16, 2016device

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 ...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

rti surgical inc dba pioneer surgical technology incrtirti surgical

UPCs

00846468027179

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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