Recall Z-1393-2016 ยท KWP Appliance, Fixation, Spinal Interlaminal
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
RTI Surgical Streamline Occipito-Cervico-Thoracic (OCT) Final Driver, Common Name: Screw Driver
| Date | Mar 18, 2016 |
| Status | Terminated |
| Reason | Multiple lots of the 26-FNLDRIVER, may have reduced mechanical strength, resulting in driver tip fracturing during use. |
| Root cause | Process design |
| Action | RTI Surgical Inc. initiated a voluntary recall of RTI Surgical Streamline OCT Occipito-Cervico-Thoracic Final Driver, via written notices sent by e-mail and FedEx on 03/18/2016. Customers are requested to review all inventory, quarantine products listed in the recall, and to immediately return recalled products with the recall reply form, and the shipping labels and authorization numbers provided within 5 days of receiving notice. Replacement drivers are being sent to customers. Customers may contact Dan Nelson, Manager of Quality Systems, Phone: 906-226-4489, Fax: 906-226-4455, e-mail: d |
| Distribution | Domestic: AL, CO, CT, FL, IN, ID, IL, MI, MS, MO, NC, NY, TX Foreign: None VA/DOD: None |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150254 | Streamline OCT Occipito-Cervico-Thoracic System Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.), Apr 28, 2015 |