FDAJanuary 13, 2022device
Everest MI XT Inner Dilator, Catalog Number 5101-90167
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Stryker received two (2) complaints for units from specific lots of Inner and Outer Dilators not fitting together properly during a surgical procedure. Some dilators from these lots and from other lots were subsequently determined to be affected by a manufacturing nonconformance.
What to do
FDA enforcement status: Ongoing
Brands named
k2m
UPCs
10888857261204
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 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
- FDAYukon Polyaxial Screw Size 4.0x26mm (catalog number 7601-04026), component of YUKON Spinal System2020-12-14
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