FDA Medical Device Recalls (openFDA)
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.): RTI Surgical Streamline Occipito-Cervico-Thoracic (OCT) Final Driver, Common Name: Screw Driver
- Recall number
- Z-1393-2016
- Recalling firm
- RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
- Product
- RTI Surgical Streamline Occipito-Cervico-Thoracic (OCT) Final Driver, Common Name: Screw Driver
- Status
- Terminated
- Initiated
- 2016-03-18
- Posted
- not on file
- Terminated
- 2016-09-12
- 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: dnelson@rtix.com.
- Quantity
- not on file
- Distribution
- Domestic: AL, CO, CT, FL, IN, ID, IL, MI, MS, MO, NC, NY, TX Foreign: None VA/DOD: None
- Lot, serial or model codes
- 26-FNLDRIVER, Lot Numbers: 177091, 177093, 183817, 207727, 223926, 227291, 229134, 230523, 232262, 233074, 234205
- 510(k) numbers
- ["K150254"]
- PMA numbers
- not on file
- Product code
- KWP
- Firm FEI
- 1000115331
- Firm city
- Marquette
- Firm state
- MI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28