United StatesAlphatec Spine’s ATEC Lateral Navigation Disc Prep Instruments (LIF NAV), OSTEOTOME 10mm REF 266-01-000-10-N UDI‑DI 00190376476179 Lot EM49968 and REF 267-01-000-10-N UDI‑DI 00190376541471 Lot EM56693 are affected. They were recalled because a design issue causes the navigated array connection geometry to be incorrect. The recall covers nationwide U.S. distribution in AZ, CA, FL, IL, IN, MA, MI, MO, NC, NH, NY, TN, TX and VA (7 units and 15 units respectively).
What's being recalled
ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 266-01-000-10-N UDI-DI code: 00190376476179; GMDN 12844 The ATEC Navigation Disc Prep Instruments are intended for use in surgical procedures. These instruments are non-sterile or sterile packaged, re-usable or single-use instruments designed to function with the Medtronic StealthStation System and NavLock Tracker.
ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 267-01-000-10-N UDI-DI code: 00190376541471; GMDN 12844 The ATEC Navigation Disc Prep Instruments are intended for use in surgical procedures. These instruments are non-sterile or sterile packaged, re-usable or single-use instruments designed to function with the Medtronic StealthStation System and NavLock Tracker.
Recalling firm: Alphatec Spine, Inc., Carlsbad, CA, United States.
How to identify it
Model/Catalog Number: 266-01-000-10-N UDI-DI code: 00190376476179 Lot Number: EM49968 Model/Catalog Number: 267-01-000-10-N UDI-DI code: 00190376541471 Lot Number: EM56693
The hazard
Due a design issue where the navigated array connection geometry is incorrect.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
U.S. Nationwide distribution in the states of AZ, CA, FL, IL, IN, MA, MI, MO, NC, NH, NY, TN, TX, and VA.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)