K2M, Inc. recalls
Every recall we track for K2M, Inc. — 38 in all, from 2018–2022 — plus the complaints and injury reports the public filed about them. 2 are rated “stop using now”.
Recalls per year, by danger level
Recalls from K2M, Inc. peaked in 2020 (27); 38 since 2017. 5% rated “stop using now”.
All FDA recall records for K2M, Inc. since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 1 | 0 | 1 |
| 2019 | 0 | 0 | 1 | 1 | 2 |
| 2020 | 2 | 21 | 3 | 1 | 27 |
| 2021 | 0 | 2 | 3 | 0 | 5 |
| 2022 | 0 | 0 | 3 | 0 | 3 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
Most common reasons for K2M, Inc. recalls
What to do if you have a recalled K2M, Inc. product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All K2M, Inc. recalls
11 shown- Lower riskMedical device
K2M, Inc. recalls Yukon Straight Rod 4.0 x120mm; Cat# 7601-540120. Used to provide immobilization and stabilization of spinal segments.
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.
K2MJun 13, 2022 - Lower riskMedical device
K2M, Inc recalls Everest MI XT Inner Dilator, Catalog Number 5101-90167
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.
K2MJan 13, 2022 - Use cautionMedical device
K2M, Inc recalls Chesapeake Anterior Lumbar (AL) Removal Tool; Cat. no. 2008-90068
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.
K2MSep 8, 2021 - Lower riskMedical device
K2M, Inc recalls Cascadia AN Interbody Convex 10x28x14mm Catalog Number: 6101-2102814NC-G2 Lumbar implants are intervertebral body
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.
K2MMay 7, 2021 - Use cautionMedical device
K2M, Inc recalls Chesapeake Cervical-Ti 10mm Drill Guide Inserter- a multi-screw construct providing stability to the anterior column
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.
K2MMar 16, 2021 - Lower riskMedical device
K2M, Inc recalls Yukon Polyaxial Screw Size 4.0x26mm (catalog number 7601-04026), component of YUKON Spinal System
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.
K2MDec 14, 2020 - Lower riskMedical device
K2M, Inc recalls 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
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.
K2MNov 4, 2020 - Lower riskMedical device
K2M, Inc recalls Yukon OCT Spinal System Yukon Anti-Torque Alignment Tube - Product Usage: The Anti-Torque Alignment Tube (the Alignment
K2M recalls Yukon Anti-Torque Alignment Tube (Lot KTGG) due to potential surgery delays. Affected users should contact K2M for details.
K2MNov 3, 2020 - Use cautionMedical device
K2M, Inc recalls K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog #
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.
K2MApr 13, 2020 - UnratedMedical device
K2M, Inc recalls Fenestrated Taps 4.5mm, 5.5mm, 6.5mm (Ref#5001-90013, 5001-90014, 5001-90015) Product Usage: The K2M Fenestrated Tap
K2M recalls Fenestrated Taps 4.5mm, 5.5mm, 6.5mm (Ref#5001-90013-5001-90015) due to mislabeling. All distributed lots are affected.
K2MApr 18, 2019 - Lower riskMedical device
K2M, Inc recalls 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
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.
K2MJul 24, 2018
K2M, Inc. recall questions
How many recalls has K2M, Inc. had?
38 recalls from K2M, Inc. are on record with U.S. safety agencies, from 2018–2022.
What is the most recent K2M, Inc. recall?
K2M, Inc. recalls Yukon Straight Rod 4.0 x120mm; Cat# 7601-540120. Used to provide immobilization and stabilization of spinal segments., dated Jun 13, 2022. Every K2M, Inc. recall is listed on this page, newest first.
Why are K2M, Inc. products recalled?
The most common reasons on record: The products are mislabeled. (2).
What should I do if I have a recalled K2M, Inc. product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new K2M, Inc. recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.