Class II — RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
| Recalling firm | RTI Surgical, Inc. (dba RTI Biologics, Inc.) |
|---|---|
| Registered facility | View this company's 3 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Multiple lots of the 26-FNLDRIVER, may have reduced mechanical strength, resulting in driver tip fracturing during use. |
| Product | RTI Surgical Streamline Occipito-Cervico-Thoracic (OCT) Final Driver, Common Name: Screw Driver |
| Quantity | N/A |
| Distribution | Domestic: AL, CO, CT, FL, IN, ID, IL, MI, MS, MO, NC, NY, TX Foreign: None VA/DOD: None |
| Initiated | 2016-03-18 |
| Classified | 2016-04-14 |
| Terminated | 2016-09-12 |
| Recall number | Z-1393-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) (Z-1393-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/73659/
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