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All Recalls

Every K2m, Inc Recall

Sorted by most recent. Click any recall for full details.

26 recalls
High RiskFDA
K2m, Inc.
Yukon Straight Rod 4.0 x120mm; Cat# 7601-540120. Used to provide immobilization and stabilization of spinal segments.
Medical Devices·53 affected·Jun 13, 2022
High RiskFDA
K2m, Inc
Everest MI XT Inner Dilator, Catalog Number 5101-90167
Medical Devices·686 affected·Jan 13, 2022
High RiskFDA
K2m, Inc
Chesapeake Anterior Lumbar (AL) Removal Tool; Cat. no. 2008-90068
Medical Devices·23 affected·Sep 8, 2021
High RiskFDA
K2m, Inc
Cascadia AN Interbody Convex 10x28x14mm Catalog Number: 6101-2102814NC-G2 Lumbar implants are intervertebral body fusion devices in...
Medical Implants·3 affected·May 7, 2021
High RiskFDA
K2m, Inc
Cascadia AN Interbody Convex 10x22x15mm Catalog Number: 6101-2102215NC-G2 Lumbar implants are intervertebral body fusion devices in...
Medical Implants·7 affected·May 7, 2021
High RiskFDA
K2m, Inc
Chesapeake Cervical-Ti 10mm Drill Guide Inserter- a multi-screw construct providing stability to the anterior column (cervical spine) Ca...
Medical Devices·1 affected·Mar 16, 2021
High RiskFDA
K2m, Inc
Yukon Polyaxial Screw Size 4.0x26mm (catalog number 7601-04026), component of YUKON Spinal System
Medical Devices·248 affected·Dec 14, 2020
High RiskFDA
K2m, Inc
Everest MI XT Tab Removal Tool (i.e. All-In-One Tab Removal Tool)-used to break the tab off the Everest XT screw by rocking the instrumen...
Medical Devices·197 affected·Nov 4, 2020
High RiskFDA
K2m, Inc
Yukon OCT Spinal System Yukon Anti-Torque Alignment Tube - Product Usage: The Anti-Torque Alignment Tube (the Alignment Tube ) provides ...
Medical Devices·4 affected·Nov 3, 2020
High RiskFDA
K2m, Inc
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90109, UDI # 1088885...
Medical Implants·0 affected·Apr 13, 2020
High RiskFDA
K2m, Inc
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90123, UDI # 1088885...
Medical Implants·0 affected·Apr 13, 2020
High RiskFDA
K2m, Inc
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90181, UDI # 1088885...
Medical Implants·0 affected·Apr 13, 2020
High RiskFDA
K2m, Inc
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90151, UDI # 1088885...
Medical Implants·0 affected·Apr 13, 2020
High RiskFDA
K2m, Inc
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90155, UDI # 1088885...
Medical Implants·0 affected·Apr 13, 2020
High RiskFDA
K2m, Inc
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90125, UDI # 1088885...
Medical Implants·0 affected·Apr 13, 2020
High RiskFDA
K2m, Inc
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90153, UDI # 1088885...
Medical Implants·0 affected·Apr 13, 2020
High RiskFDA
K2m, Inc
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90177, UDI # 1088885...
Medical Implants·0 affected·Apr 13, 2020
High RiskFDA
K2m, Inc
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90149, UDI # 1088885...
Medical Implants·0 affected·Apr 13, 2020
High RiskFDA
K2m, Inc
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90165, UDI # 1088885...
Medical Implants·0 affected·Apr 13, 2020
High RiskFDA
K2m, Inc
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90107, UDI # 1088885...
Medical Implants·211 affected·Apr 13, 2020
High RiskFDA
K2m, Inc
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90167, UDI # 1088885...
Medical Implants·0 affected·Apr 13, 2020
High RiskFDA
K2m, Inc
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90127, UDI # 1088885...
Medical Implants·0 affected·Apr 13, 2020
High RiskFDA
K2m, Inc
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90169, UDI # 1088885...
Medical Implants·0 affected·Apr 13, 2020
High RiskFDA
K2m, Inc
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90163, UDI # 1088885...
Medical Implants·0 affected·Apr 13, 2020
High RiskFDA
K2m, Inc
YUKON Polyaxial Screws (3.5 X 12 mm, Owning Site: Leesburg USA 3.5 X 14 mm, 3.5 X 32 mm, 3.5 X 34 mm, 3.5 X 38 mm, 3.5 X 40 mm, 4.0 X 16...
Medical Devices·364 affected·Jul 24, 2018
High RiskFDA
K2m, Inc
K2M Special Connector Instruments (Special Connector, Special Adaptor, and Quick Adaptor) Product Usage: Special Connector Instrument...
Surgical Devices·503 affected·Dec 2, 2016