The Recall Desk

FDA (Devices) recall action 86559

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) recalled 2 products on 2020-11-04

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2020-11-04
Critical
0
Units
840

Why these products were recalled

The Streamline Navigation System taps have experienced binding with other devices.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2020-11-04

    RTI Surgical Recalls Streamline MIS Navigation System Taps Due to Binding

    RTI Surgical is recalling 420 units of Streamline MIS Navigation System Taps because they have experienced binding with other devices.

    Product
    Streamline MIS Navigation System Taps, Catalog Nos. 04-CANNDRILL-MDN 04-CANNTAP-40-MDN 04-CANNTAP-45-MDN 04-CANNTAP-55-MDN 04-CANNTAP-65-MDN 04-CANNTAP-75-MDN 04-CANNTAP-85-MDN 04-CTAP-TT-65-MDN 04-S-FINDER-MDN 05-SCREWINS-CL-MDN 05-SIMPDRIVER-MDN Product Usage: i
    Category
    Distribution
    2 states
  • ModerateFDA (Devices)··2020-11-04

    RTI Surgical Recalls Streamline TL Navigation System Taps Due to Binding

    RTI Surgical is recalling 420 units of Streamline TL Navigation System taps because they have experienced binding with other devices.

    Product
    Streamline TL Navigation System, Catalog Nos. 02-C-TAP-55-MDN 02-C-TAP-60-L-MDN 02-C-TAP-65-L-MDN 02-C-TAP-65-MDN 02-C-TAP-75-L-MDN 02-C-TAP-85-L-MDN 02-C-TAP-85-MDN 02-C-TAP-95-L-MDN 02-RS-INS-C-MDN 02-RS-INSERTER-MDN 02-SCREWINS-CL-MDN 02-SCREWINS-C-MDN 02-S-FIN
    Category
    Distribution
    2 states