RTI Surgical Streamline OCT Occipito-Cervico-Thoracic recall
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…
Why was RTI Surgical Streamline OCT Occipito-Cervico-Thoracic 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models 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
- 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…
- Recalling firm
- RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
- Quantity
- 66
- Distribution
- US Nationwide Distribution in the states of: AL, CA, CO, FL, IN, IL, MI, MO, MS, NC, NY, OK, TN, TX, and VA,.
- Recall date
- October 26, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)