Recall Z-1393-2016
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) · initiated March 18, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
RTI Surgical Streamline Occipito-Cervico-Thoracic (OCT) Final Driver, Common Name: Screw Driver
Codes / lots: 26-FNLDRIVER, Lot Numbers: 177091, 177093, 183817, 207727, 223926, 227291, 229134, 230523, 232262, 233074, 234205
Reason for recall
Multiple lots of the 26-FNLDRIVER, may have reduced mechanical strength, resulting in driver tip fracturing during use.
FDA-determined cause: Process design
Action taken
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: dnelson@rtix.com.
Details
- Recall number
- Z-1393-2016
- Initiated
- March 18, 2016
- Terminated
- September 12, 2016
- Product code
- KWP – Appliance, Fixation, Spinal Interlaminal
- Distribution
- Domestic: AL, CO, CT, FL, IN, ID, IL, MI, MS, MO, NC, NY, TX Foreign: None VA/DOD: None
- Recalling firm
- RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.), Marquette, MI