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K2M, Inc. FDA Recalls
8 recalls on file across devices, 0 of them Class I and 3 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Yukon Straight Rod 4.0 x120mm; Cat# 7601-540120. Used to provide immobilization and stabilization of spinal segments.Class IIJun 13, 2022Some of the rods in this lot were observed to have discolora |
| Everest MI XT Inner Dilator, Catalog Number 5101-90167Class IIJan 13, 2022Stryker received two (2) complaints for units from specific |
| Everest MI XT Outer Dilator, Catalog Number 5101-90168Class IIJan 13, 2022Stryker received two (2) complaints for units from specific |
| Chesapeake Anterior Lumbar (AL) Removal Tool; Cat. no. 2008-90068Class IISep 8, 2021Units may arrive with missing pins and/or in a state in disa |
| Cascadia AN Interbody Convex 10x28x14mm Catalog Number: 6101-2102814NC-G2 Lumbar implants are intervertebral body Class IIMay 7, 2021Mislabeled product labeling references incorrect length or h |
| Cascadia AN Interbody Convex 10x22x14mm Catalog Number: 6101-2102214NC-G2 Lumbar implants are intervertebral body fuClass IIMay 7, 2021Mislabeled product labeling references incorrect length or h |
| Cascadia AN Interbody Convex 10x22x15mm Catalog Number: 6101-2102215NC-G2 Lumbar implants are intervertebral body Class IIMay 7, 2021Mislabeled product labeling references incorrect length or h |
| Chesapeake Cervical-Ti 10mm Drill Guide Inserter- a multi-screw construct providing stability to the anterior column (ceClass IIMar 16, 2021Interference condition between the 10mm Drill Guide Inserter |