FDAApril 13, 2020device
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90149, UDI # 10888857108622, Size 28x4mm, 6 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal implant size base on pat...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.
What to do
FDA enforcement status: Terminated
Brands named
k2m
UPCs
10888857108622
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 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
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