Every recall we track for K2M, Inc. — 38 in all — plus the complaints and injury reports the public filed about them.
K2M recalls Yukon Straight Rod 4.0x120mm (Cat# 7601-540120) due to trace inorganic phosphorous causing mild irritation. Affected spinal stabilization rods may cause tissue inflammation.
K2M recalls Everest MI XT Outer Dilators (Catalog 5101-90168) due to improper fit during surgery. Affected units may not assemble correctly, risking surgical complications.
K2M recalls Everest MI XT Inner Dilators (Catalog 5101-90167) due to improper fit during surgery. Affected units may not assemble correctly, risking surgical complications.
K2M recalls Chesapeake Anterior Lumbar Removal Tools with possible missing pins that could dislodge during surgery, requiring extra procedures. Affected units include specific model numbers and lots.
K2M recalls specific lumbar fusion implants due to incorrect size labeling that could lead to improper surgical use. Affected products have catalog numbers 6101-2102214NC-G2 and lot numbers NCMR-4437922.
K2M recalls specific lumbar fusion implants due to incorrect size labeling that could lead to improper surgical fit. Affected units have catalog number 6101-2102215NC-G2 and lot numbers NCMT-4437923.
K2M recalls specific lumbar fusion implants due to incorrect size labeling that could lead to improper surgical fit. Affected products have catalog number 6101-210281: 10x22x14mm, 10x28x14mm, 10x22x15mm. Check your lot numbers for recall.
K2M recalls Chesapeake Cervical-Ti 10mm Drill Guide Inserter due to risk of spinal cord injury from improper implant seating. Affected units have catalog number 3608-90033 and lot number MNAJ.
K2M recalls Yukon Polyaxial Screw Size 4.0x26mm (catalog 7601-04026) due to incorrect laser marking. This may lead to improper spinal surgery use. Affected units have lot number KRBX.
K2M recalls Everest MI XT Tab Removal Tools due to cracking at the metal shaft and handle interface, which may cause Loctite leakage. Affected units have specific catalog and lot numbers.
K2M recalls Yukon Anti-Torque Alignment Tube (Lot KTGG) due to potential surgery delays. Affected users should contact K2M for details.
K2M recalls Aleutian Anatomically Narrow Lordotic Spreader systems due to risk of spreader tip breaking during spinal surgery procedures.
K2M recalls Aleutian Anatomically Narrow Lordotic Spreader systems due to risk of spreader tip breaking during spinal surgery procedures. Affected units have specific catalog numbers and lot codes.
K2M recalls Aleutian Anatomically Narrow Lordotic Spreader systems due to risk of spreader tip breaking during spinal procedures. Affected units have specific catalog and lot numbers. Contact K2M for details.
K2M recalls Aleutian Anatomically Narrow Lordotic Spreader systems due to risk of tip breaking off during spinal procedures. Affected units have specific catalog and lot numbers.
K2M recalls Aleutian Anatomically Narrow Lordotic Spreader systems due to risk of spreader tip breaking during spinal surgery procedures. Affected models include specific catalog numbers and lot numbers.
K2M recalls Aleutian Anatomically Narrow Lordotic Spreader systems due to risk of spreader tip breaking during spinal surgery procedures. Affected units have specific catalog and lot numbers.
K2M recalls Aleutian Anatomically Narrow Lordotic Spreader systems due to risk of spreader tip breaking during spinal procedures. Affected units have specific catalog and lot numbers. Contact K2M for details.
K2M recalls Aleutian Anatomically Narrow Lordotic Spreader systems due to risk of spreader tip breaking during spinal procedures. Affected units have specific catalog and lot numbers. Contact for return instructions.
K2M recalls Aleutian Anatomically Narrow Lordotic Spreader systems due to risk of spreader tip breaking during spinal surgery procedures. Affected units have specific model and lot numbers.
K2M recalls Aleutian Anatomically Narrow Lordotic Spreader systems due to risk of spreader tip breaking during spinal procedures. Affected units have specific catalog and lot numbers.
K2M recalls Aleutian Interbody Spacer Systems due to risk of spreader tip breaking off during spinal procedures. Affected units have specific catalog numbers and lot codes.
K2M recalls Aleutian Anatomically Narrow Lordotic Spreader systems due to risk of tip breaking during spinal procedures. Affected units have specific catalog and lot numbers. Contact for replacement.
K2M recalls Aleutian Anatomically Narrow Lordotic Spreader systems due to risk of spreader tip breaking during spinal procedures. Affected units have specific catalog and lot numbers.
K2M recalls Aleutian Interbody Spacer Systems due to risk of spreader tip breaking off during spinal procedures. Affected units include specific model and lot numbers.
K2M recalls Aleutian Interbody Spacer Systems due to risk of spreader tip breaking off during spinal procedures. Affected units include specific model and lot numbers. Consumers should contact K2M for details.
K2M recalls Aleutian Interbody Spacer Systems due to risk of spreader tip breaking during spinal surgery, potentially causing complications. Affected units include specific model and lot numbers.
K2M recalls Aleutian Anatomically Narrow Lordotic Spreader systems due to risk of tip breaking off during spinal procedures. Affected units have specific catalog and lot numbers.
K2M recalls Aleutian Interbody Spacer Systems with a risk of spreader tip breaking during spinal procedures. Affected units have specific catalog and lot numbers. Contact K2M for details.
K2M recalls Aleutian Interbody Spacer Systems due to risk of spreader tip breaking off during spinal procedures. Affected units include specific model and lot numbers. Contact for return instructions.
K2M recalls Aleutian Anatomically Narrow Lordotic Spreader systems due to risk of spreader tip breaking off during spinal procedures. Affected units have specific catalog and lot numbers.
K2M recalls Aleutian Anatomically Narrow Lordotic Spreader systems due to risk of spreader tip breaking during spinal procedures. Affected units have specific catalog and lot numbers.
K2M recalls Aleutian Anatomically Narrow Lordotic Spreader systems due to risk of spreader tip breaking off during spinal procedures. Affected units have specific catalog and lot numbers.
K2M recalls Aleutian Anatomically Narrow Lordotic Spreader systems due to risk of tip breaking during spinal procedures. Affected units have specific catalog and lot numbers. Contact for return instructions.
K2M recalls Aleutian Anatomically Narrow Lordotic Spreader systems due to risk of spreader tip breaking during spinal procedures. Affected units include specific catalog numbers and lot numbers. Contact K2M for details.
K2M recalls fenestrated tap adapters (REF# 5001-90011) due to mislabeling. The product is intended for bone biopsy and spinal cement procedures but may be mislabeled, affecting safe use in medical settings.
K2M recalls Fenestrated Taps 4.5mm, 5.5mm, 6.5mm (Ref#5001-90013-5001-90015) due to mislabeling. All distributed lots are affected.
K2M recalls YUKON Polyaxial Screws (3.5 X 12 mm to 5.0 X 30 mm) due to a manufacturing error that may prevent screws from mating with inserters. This affects medical devices sold in the U.S. since 2018.
