K2M recalls
3 official recalls and safety alerts involving K2M since 2021-10, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with K2M or the relevant agency.
- 2022-07-06
USK2M, Inc. recalls Yukon Straight Rod 4.0 x120mm; Cat# 7601-540120. Used to provide immobilization and stabilization of spinal segments.
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;…
FDA · DeviceK2M, Inc.Domestic distribution to FL GA NE NV NY OH OK SC Foreign distribution to…Official notice →- 2022-03-09
- US
K2M, Inc recalls Everest MI XT Inner Dilator, Catalog Number 5101-90167
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…
- 2021-10-20
- US
K2M, Inc recalls Chesapeake Anterior Lumbar (AL) Removal Tool; Cat. no. 2008-90068
Units may arrive with missing pins and/or in a state in disassembly. Pins dislodging from the instrument during a procedure may enter the surgical cavity, requiring intraoperative removal or revision surgery.
FDA · DeviceK2M, IncDomestic distribution to CO, IL, LA, MA, MS, OK, PA, TN, and TX. Foreign…Official notice →