FDANovember 3, 2020device
Yukon OCT Spinal System Yukon Anti-Torque Alignment Tube - Product Usage: The Anti-Torque Alignment Tube (the Alignment Tube ) provides counter rotation to reduce the torque applied to the anatomy when the size 15 Torque limiting shaft (the shaft is used to tighten the Yukon Set Screw to the spec...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Shafts do not pass through the inner cannula of the Anti-Torque Alignment Tube from Lot KTGG due to a manufacturing nonconformance. This could result in a delay of surgery or result in surgical intervention later on.
What to do
FDA enforcement status: Terminated
Brands named
k2m
UPCs
10888857343948
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAYukon Straight Rod 4.0 x120mm; Cat# 7601-540120. Used to provide immobilization and stabilization of spinal segments.2022-06-13
- FDAEverest MI XT Inner Dilator, Catalog Number 5101-901672022-01-13
- FDAEverest MI XT Outer Dilator, Catalog Number 5101-901682022-01-13
- FDAChesapeake Anterior Lumbar (AL) Removal Tool; Cat. no. 2008-900682021-09-08
- FDACascadia AN Interbody Convex 10x22x15mm Catalog Number: 6101-2102215NC-G2 Lumbar implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as anadjunct to fusion in patients wi...2021-05-07
- FDACascadia AN Interbody Convex 10x22x14mm Catalog Number: 6101-2102214NC-G2 Lumbar implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as anadjunct to fusion in patients wi...2021-05-07
- FDACascadia AN Interbody Convex 10x28x14mm Catalog Number: 6101-2102814NC-G2 Lumbar implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as anadjunct to fusion in patients wi...2021-05-07
- FDAChesapeake Cervical-Ti 10mm Drill Guide Inserter- a multi-screw construct providing stability to the anterior column (cervical spine) Catalog number: 3608-900332021-03-16
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