Streamline OCT Occipito-Cervico-Thoracic System, Crosslink Counter Torque Sleeve. Spinal fixation device instrument.
FDA device recall Z-1829-2016 · posted 2016-05-26 · Terminated
Recall details
- Recalling firm
- RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
- Reason for recall
- Potential for a product defect where the cannula may be obstructed. This obstruction could prevent a driver from going through, which increases the potential for the driver to slip, resulting in possible patient injury.
- Action taken
- RTI sent an Urgent Voluntary Product Notification dated April 22, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. RTI Surgical is conducting a voluntary recall of the Streamline OCT Occipito-Cervico-Thoracic System, Crosslink Counter Torque Sleeve due to the potential for a product defect where the cannula may be obstructed. This obstruction could prevent a driver from going through, which increases the potential for the driver to slip resulting in possible patient injury. For further questions, please call (906) 226-4489.
- Root cause
- Process design
- Status
- Terminated
- Product code
- KWP
- Quantity affected
- 17 devices
- Distribution
- US nationwide distribution in CA, FL, IN, MI, MO, NC, NY, and TX.
- Date initiated
- 2016-04-22
- Date posted
- 2016-05-26
- Date terminated
- 2017-02-08
- Location
- Marquette, MI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Streamline OCT Occipito-Cervico-Thoracic System (K150254) | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | 2015-04-28 |