K2M, Inc
Complete recall history across all FDA and CPSC categories — 38 total recalls
K2M, Inc appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (38)
FDA medical device enforcement actions by K2M, Inc
| Date | Product | Reason | Class |
|---|---|---|---|
| Jan 13, 2022 | Everest MI XT Outer Dilator, Catalog Number 5101-90168 | Stryker received two (2) complaints for units from specific lots of Inner and... | Class II |
| Jan 13, 2022 | Everest MI XT Inner Dilator, Catalog Number 5101-90167 | Stryker received two (2) complaints for units from specific lots of Inner and... | Class II |
| Sep 8, 2021 | Chesapeake Anterior Lumbar (AL) Removal Tool; Cat. no. 2008-90068 | Units may arrive with missing pins and/or in a state in disassembly. Pins dis... | Class II |
| May 7, 2021 | Cascadia AN Interbody Convex 10x22x14mm Catalog Number: 6101-2102214NC-G2 ... | Mislabeled product labeling references incorrect length or height, or length ... | Class II |
| May 7, 2021 | Cascadia AN Interbody Convex 10x22x15mm Catalog Number: 6101-2102215NC-G2 ... | Mislabeled product labeling references incorrect length or height, or length ... | Class II |
| May 7, 2021 | Cascadia AN Interbody Convex 10x28x14mm Catalog Number: 6101-2102814NC-G2 ... | Mislabeled product labeling references incorrect length or height, or length ... | Class II |
| Mar 16, 2021 | Chesapeake Cervical-Ti 10mm Drill Guide Inserter- a multi-screw construct pro... | Interference condition between the 10mm Drill Guide Inserter and the inner sh... | Class II |
| Dec 14, 2020 | Yukon Polyaxial Screw Size 4.0x26mm (catalog number 7601-04026), component o... | The Yukon polyaxial screw used in the Yukon Spinal System was incorrectly las... | Class II |
| Nov 4, 2020 | Everest MI XT Tab Removal Tool (i.e. All-In-One Tab Removal Tool)-used to bre... | All-in-One Tab Removal Tool may cause cracking and/or separating at the threa... | Class II |
| Nov 3, 2020 | Yukon OCT Spinal System Yukon Anti-Torque Alignment Tube - Product Usage: The... | Shafts do not pass through the inner cannula of the Anti-Torque Alignment Tub... | Class II |
| Apr 13, 2020 | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless St... | The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pi... | Class II |
| Apr 13, 2020 | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless St... | The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pi... | Class II |
| Apr 13, 2020 | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless St... | The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pi... | Class II |
| Apr 13, 2020 | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless St... | The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pi... | Class II |
| Apr 13, 2020 | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless St... | The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pi... | Class II |
| Apr 13, 2020 | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless St... | The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pi... | Class II |
| Apr 13, 2020 | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless St... | The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pi... | Class II |
| Apr 13, 2020 | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless St... | The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pi... | Class II |
| Apr 13, 2020 | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless St... | The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pi... | Class II |
| Apr 13, 2020 | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless St... | The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pi... | Class II |
| Apr 13, 2020 | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless St... | The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pi... | Class II |
| Apr 13, 2020 | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless St... | The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pi... | Class II |
| Apr 13, 2020 | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless St... | The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pi... | Class II |
| Apr 13, 2020 | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless St... | The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pi... | Class II |
| Apr 13, 2020 | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless St... | The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pi... | Class II |
| Apr 13, 2020 | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless St... | The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pi... | Class II |
| Apr 13, 2020 | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless St... | The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pi... | Class II |
| Apr 13, 2020 | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless St... | The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pi... | Class II |
| Apr 13, 2020 | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless St... | The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pi... | Class II |
| Apr 13, 2020 | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless St... | The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pi... | Class II |
| Apr 13, 2020 | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless St... | The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pi... | Class II |
| Apr 13, 2020 | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless St... | The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pi... | Class II |
| Apr 13, 2020 | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless St... | The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pi... | Class II |
| Apr 13, 2020 | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless St... | The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pi... | Class II |
| Apr 18, 2019 | Fenestrated Tap Adapter (REF# 5001-90011) Product Usage: The K2M Fenestra... | The products are mislabeled. | Class II |
| Apr 18, 2019 | Fenestrated Taps 4.5mm, 5.5mm, 6.5mm (Ref#5001-90013, 5001-90014, 5001-90015)... | The products are mislabeled. | Class II |
| Jul 24, 2018 | YUKON Polyaxial Screws (3.5 X 12 mm, Owning Site: Leesburg USA 3.5 X 14 mm, ... | Screws had a manufacturing error that could prevent the screw from mating wit... | Class II |
| Dec 2, 2016 | K2M Special Connector Instruments (Special Connector, Special Adaptor, and Qu... | Instruments were developed without adequate consideration given to the need f... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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