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 dis
Check against the official notice below — it lists the full affected range.
RTI Surgical, Inc. is voluntarily recalling two specific lots of the Streamline OCT Occipito-Cervico-Thoracic Spinal Rod (3.2mm diameter x 240mm length, CoCr material) due to the potential presence of small cracks on the rods. These cracks could reduce the strength of spinal implants using these rods, potentially causing patient injury. A total of 66 units were distributed nationwide across 15 states: Alabama, California, Colorado, Florida, Indiana, Illinois, Michigan, Missouri, Mississippi, North Carolina, New York, Oklahoma, Tennessee, Texas, and Virginia.
The affected products are identified by Part Number 23-CC-ROD-240 in two lots: Lot Number 234829 (UDI: 00846468027179-234829) and Lot Number 246678 (UDI: 00846468027179-246678). The source document does not specify what remedy or action affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Distribution: US Nationwide Distribution in the states of: AL, CA, CO, FL, IN, IL, MI, MO, MS, NC, NY, OK, TN, TX, and VA,. Quantity: 66 Lot/code info: 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.