FDAJune 13, 2022device
Yukon Straight Rod 4.0 x120mm; Cat# 7601-540120. Used to provide immobilization and stabilization of spinal segments.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Some of the rods in this lot were observed to have discoloration, later confirmed to be indication of trace amounts of inorganic phosphorous compound. This may produce a mild irritating or inflammatory response; adverse local tissue reactions may occur related to cytotoxicity with the nonconforming rod and surrounding tissue.
What to do
FDA enforcement status: Ongoing
Brands named
k2m
UPCs
10888857326804
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAEverest MI XT Outer Dilator, Catalog Number 5101-901682022-01-13
- FDAEverest MI XT Inner Dilator, Catalog Number 5101-901672022-01-13
- FDAChesapeake Anterior Lumbar (AL) Removal Tool; Cat. no. 2008-900682021-09-08
- 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
- 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 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
- 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
- FDAYukon Polyaxial Screw Size 4.0x26mm (catalog number 7601-04026), component of YUKON Spinal System2020-12-14
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