Manufacturer

K2M, Inc.

39 recalls in our database name K2M, Inc. as the manufacturing or recalling firm.

What the numbers show

Total: 39
Critical: 0
Severe: 18
Most recent: 2022-07-06

Of the 39 recalls from K2M, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 18 (46%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

26–39 of 39

SevereFDA (Devices)·Z-2027-2020·2020-05-27
K2M Aleutian Lordotic Spreader Recalled Due to Tip Breakage Risk
K2M, Inc. is recalling Aleutian Lordotic Spreaders because the welded tips may break off during spinal procedures.
Product
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90167, UDI # 10888857108806, Size 28x8mm, 12 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal impla
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2022-2020·2020-05-27
K2M Aleutian Lordotic Spreader Recalled Due to Tip Breakage Risk
K2M, Inc. is recalling Aleutian Lordotic Spreaders because the welded tips may break off during spinal procedures.
Product
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90153, UDI # 10888857108660, Size 28x8mm, 6 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal implan
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2009-2020·2020-05-27
K2M Recalls Aleutian Lordotic Spreader Due to Tip Breakage Risk
K2M, Inc. is recalling the Aleutian Anatomically Narrow Lordotic Spreader because the welded tip may break off during spinal procedures.
Product
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90109, UDI # 10888857108226, Size 24x6mm, 6 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal implan
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2016-2020·2020-05-27
K2M Aleutian Lordotic Spreader Recalled for Tip Breakage Risk
K2M, Inc. is recalling the Aleutian Anatomically Narrow Lordotic Spreader because the welded tip may break off during surgical procedures.
Product
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90127, UDI # 10888857108400, Size 24x10mm, 12 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal impl
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2011-2020·2020-05-27
K2M Aleutian Lordotic Spreader Recalled Due to Tip Breakage Risk
K2M, Inc. is recalling Aleutian Lordotic Spreaders because the welded tips may break off during spinal procedures.
Product
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90113, UDI # 10888857108264, Size 24x10mm, 6 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal impla
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2014-2020·2020-05-27
K2M Aleutian Lordotic Spreader Recalled Due to Tip Breakage Risk
K2M, Inc. is recalling the Aleutian Interbody Spacer Systems Lordotic Spreader because the welded tip may break off during surgical procedures.
Product
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90123, UDI # 10888857108363, Size 24x6mm, 12 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal impla
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2028-2020·2020-05-27
K2M Recalls Aleutian Lordotic Spreader Due to Tip Breakage Risk
K2M, Inc. is recalling the Aleutian Anatomically Narrow Lordotic Spreader because the welded tip can break off during spinal procedures.
Product
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90169, UDI # 10888857108820, Size 28x10mm, 12 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal impl
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2020-2020·2020-05-27
K2M Aleutian Lordotic Spreader Recalled Due to Tip Breakage Risk
K2M, Inc. is recalling the Aleutian Anatomically Narrow Lordotic Spreader because the welded tip may break off during surgical procedures.
Product
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90149, UDI # 10888857108622, Size 28x4mm, 6 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal implan
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2019-2020·2020-05-27
K2M Aleutian Lordotic Spreader Recalled for Tip Breakage Risk
K2M, Inc. is recalling Aleutian Lordotic Spreader systems because the welded tips may break off during spinal procedures.
Product
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90139, UDI # 10888857108523, Size 24x8mm, 18 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal impla
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2026-2020·2020-05-27
K2M Aleutian Lordotic Spreader Recalled for Welded Tip Breakage Risk
K2M, Inc. is recalling the Aleutian Anatomically Narrow Lordotic Spreader because the welded tip may break off during surgical procedures.
Product
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90165, UDI # 10888857108783, Size 28x6mm, 12 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal impla
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0110-2020·2019-10-16
K2M Recalls Yukon Polyaxial Screws Due to Manufacturing Error
K2M, Inc. is recalling Yukon Polyaxial Screws because a manufacturing error may prevent them from mating with the screw inserter or set screw as intended.
Product
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 mm, 4.0 X 18 mm, 4.0 X 20 mm, 4.0 X 22 mm, 4.0 X 24 mm, 4.0 X 26 mm, 4.0 X 28 mm, 4.0 X 30 mm, 5.0 X 22 mm, 5.0 X 28 mm, 5.0 X 30 mm) Cat
Category
Medical Device
Distribution
20 states
ModerateFDA (Devices)·Z-0052-2020·2019-10-16
K2M Special Connector Instruments Recalled for Regulatory Filing Deficiencies
K2M, Inc. is recalling 503 Special Connector Instruments because they were developed without adequate consideration for a new regulatory filing.
Product
K2M Special Connector Instruments (Special Connector, Special Adaptor, and Quick Adaptor) Product Usage: Special Connector Instruments include an additional feature on their shafts that enable surgeon users to combine them with non-K2M navigation systems as part of their stan
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1492-2019·2019-06-05
K2M Fenestrated Tap Adapter Recalled for Mislabeled Packaging
K2M, Inc. is recalling 462 Fenestrated Tap Adapters because the products are mislabeled. The devices are used for bone biopsies and vertebral body augmentation.
Product
Fenestrated Tap Adapter (REF# 5001-90011) Product Usage: The K2M Fenestrated Tap System is intended for use as a standalone biopsy tool to remove a sample of bone tissue from a vertebral body for diagnostic purposes using an aspiration technique, as well as to provide and mai
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-1491-2019·2019-06-05
K2M Fenestrated Taps Recalled for Mislabeled Packaging
K2M, Inc. is recalling 462 Fenestrated Taps because the products are mislabeled. The devices were distributed to six US states.
Product
Fenestrated Taps 4.5mm, 5.5mm, 6.5mm (Ref#5001-90013, 5001-90014, 5001-90015) Product Usage: The K2M Fenestrated Tap System is intended for use as a standalone biopsy tool to remove a sample of bone tissue from a vertebral body for diagnostic purposes using an aspiration tech
Category
Medical Device
Distribution
6 states