Reported Nov 4, 2020 · Terminated
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…
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) · 375 River Park Cir · Marquette, MI · 49855-1781
Is this the product you have?
- Streamline TL Navigation System, Catalog Nos.
02-C-TAP-55-MDN02-C-TAP-60-L-MDN02-C-TAP-65-L-MDN02-C-TAP-65-MDN02-C-TAP-75-L-MDN02-C-TAP-85-L-MDN02-C-TAP-85-MDN02-C-TAP-95-L-MDN02-RS-INS-C-MDN02-RS-INSERTER-MDN02-SCREWINS-CL-MDN02-SCREWINS-C-MDN02-S-FINDER-L-MDN02-SFINDER-MDN02-S-FINDER-T-MDN02-TAP-45-MDN02-TAP-55-MDN02-TAP-60-L-MDN02-TAP-65-L-MDN02-TAP-65-MDN02-TAP-75-L-MDN02-TAP-75-MDN02-TAP-85-L-MDN02-TAP-85-MDN02-TAP-95-L-MDN02-MODHANDLE-MDN
- Product Usageintended to be used during the preparation and placement of screws from the Streamline TL and MIS Systems and preparation of screws from the Streamline OCT System during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures
- Lot codes and dates
- Lots
372816377619372817372813372927373852377616377620372926372925372923372924366798367040366799370212371729377621371730373437371731372815377622373845377623369372370853377624
- Lots
- Amount recalled
- 420
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- MI
Why it was recalled
The Streamline Navigation System taps have experienced binding with other devices.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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