Leesburg, VA, United States
K2M, Inc recalls
12 recalls recorded since 2018, most recently on 13 June 2022. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls12
Ongoing (FDA)2
Terminated or completed10
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 13 June 2022
- Reason
- Some of the rods in this lot were observed to have discoloration, later confirmed to be indication of trace amounts of inorganic phosphorous compound. This may produce a mild irritating or inflammatory response; adverse local tissue reactions may occur related to cytotoxicity with the nonconforming rod and surrounding tissue.
- Distribution
- Domestic distribution to FL GA NE NV NY OH OK SC Foreign distribution to Canada, EU, and Hong Kong.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1307-2022
- Yukon Straight Rod 4.0 x120mm; Cat# 7601-540120. Used to provide immobilization and stabilization of spinal segments.
Ongoing Class II Medical devices
- Recall started
- 13 January 2022
- Reason
- Stryker received two (2) complaints for units from specific lots of Inner and Outer Dilators not fitting together properly during a surgical procedure. Some dilators from these lots and from other lots were subsequently determined to be affected by a manufacturing nonconformance.
- Distribution
- Worldwide distribution - US Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0705-2022, Z-0706-2022
- Everest MI XT Inner Dilator, Catalog Number 5101-90167
- Everest MI XT Outer Dilator, Catalog Number 5101-90168
Terminated Class II Medical devices
- Recall started
- 8 September 2021
- Terminated
- 17 May 2024
- Reason
- Units may arrive with missing pins and/or in a state in disassembly. Pins dislodging from the instrument during a procedure may enter the surgical cavity, requiring intraoperative removal or revision surgery.
- Distribution
- Domestic distribution to CO, IL, LA, MA, MS, OK, PA, TN, and TX. Foreign distribution to Columbia, UK, Netherlands, and Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0104-2022
- Chesapeake Anterior Lumbar (AL) Removal Tool; Cat. no. 2008-90068
Terminated Class II Medical devices
- Recall started
- 7 May 2021
- Terminated
- 8 March 2023
- Reason
- Mislabeled product labeling references incorrect length or height, or length and height for specific Lots, Sizes 10x22x14mm, 10x28x14mm, 10x22x15mm
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of MA, MI, NJ, PA, UT and the countries of Italy, Netherlands.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1697-2021, Z-1696-2021, Z-1695-2021
- Cascadia AN Interbody Convex 10x28x14mm Catalog Number: 6101-2102814NC-G2 Lumbar implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous
- Cascadia AN Interbody Convex 10x22x15mm Catalog Number: 6101-2102215NC-G2 Lumbar implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous
- Cascadia AN Interbody Convex 10x22x14mm Catalog Number: 6101-2102214NC-G2 Lumbar implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous an
Terminated Class II Medical devices
- Recall started
- 16 March 2021
- Terminated
- 12 August 2021
- Reason
- Interference condition between the 10mm Drill Guide Inserter and the inner shaft that mates with the inserters. As a result, inner shafts do not mate flush with the collet inserters, and splaying of the collet. If implant falls into the spinal cord may cause a spinal cord injury or Incomplete seating of the inserter to the implant could result in misalignment of the screws with the inserter screw guide, potentially causing malposition of the screws into the adjacent vertebral bodies
- Distribution
- PA
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1410-2021
- Chesapeake Cervical-Ti 10mm Drill Guide Inserter- a multi-screw construct providing stability to the anterior column (cervical spine) Catalog number: 3608-90033
Terminated Class II Medical devices
- Recall started
- 14 December 2020
- Terminated
- 11 July 2023
- Reason
- The Yukon polyaxial screw used in the Yukon Spinal System was incorrectly laser marked with size 5.0 mm (diameter) & 24 mm (length).
- Distribution
- Domestic: Nationwide Foreign: Australia, Canada, Netherlands, Singapore
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0931-2021
- Yukon Polyaxial Screw Size 4.0x26mm (catalog number 7601-04026), component of YUKON Spinal System
Terminated Class II Medical devices
- Recall started
- 4 November 2020
- Terminated
- 22 February 2024
- Reason
- All-in-One Tab Removal Tool may cause cracking and/or separating at the threaded interface between tool s metal shaft component and handle, resulting in leakage of Loctite from handle cracks
- Distribution
- Nationwide Foreign: Netherlands, Spain, UK, Belgium, Germany, Italy, Norway and Sweden
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0542-2021
- 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 instrument back and forth until the entire tab is fully detached from the screw head. Catal
Terminated Class II Medical devices
- Recall started
- 3 November 2020
- Terminated
- 12 January 2021
- Reason
- Shafts do not pass through the inner cannula of the Anti-Torque Alignment Tube from Lot KTGG due to a manufacturing nonconformance. This could result in a delay of surgery or result in surgical intervention later on.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0520-2021
- Yukon OCT Spinal System Yukon Anti-Torque Alignment Tube - Product Usage: The Anti-Torque Alignment Tube (the Alignment Tube ) provides counter rotation to reduce the torque applied to the anatomy when the size 15 Torqu
Terminated Class II Medical devices
- Recall started
- 13 April 2020
- Terminated
- 15 November 2021
- Reason
- The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of Colorado, Michigan, Texas, California, New York, Florida, Maryland, Oregon, Kansas, Montana, Missouri and the country of Europe.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2009-2020, Z-2014-2020, Z-2031-2020, Z-2021-2020, Z-2023-2020, Z-2015-2020, Z-2022-2020, Z-2029-2020, Z-2020-2020, Z-2026-2020, Z-2008-2020, Z-2027-2020 and 12 more
- 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
- 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 an
- K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90181, UDI # 10888857108943, Size 28x8mm, 18 Product Usage: Used to simulate the height of the cage an
- K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90151, UDI # 10888857108646, Size 28x6mm, 6 Product Usage: Used to simulate the height of the cage and
- K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90155, UDI # 10888857108684, Size 28x10mm, 6 Product Usage: Used to simulate the height of the cage an
- K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90125, UDI # 10888857108387, Size 24x8mm, 12 Product Usage: Used to simulate the height of the cage an
- 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
- K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90177, UDI # 10888857108905, Size 28x4mm, 18 Product Usage: Used to simulate the height of the cage an
- and 16 more product lines
Terminated Class II Medical devices
- Recall started
- 18 April 2019
- Terminated
- 19 June 2020
- Reason
- The products are mislabeled.
- Distribution
- The products were distributed to the following US states: FL, KY, MI, PA, SC, and WV.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1491-2019, Z-1492-2019
- 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 ver
- 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
Terminated Class II Medical devices
- Recall started
- 24 July 2018
- Terminated
- 1 October 2020
- Reason
- Screws had a manufacturing error that could prevent the screw from mating with the screw inserter or set screw as intended. This event was reported to FDA as part of Stryker's retrospective review of K2M product field actions; the action was completed in 2018.
- Distribution
- Distributed to accounts in AL, CA, CO, FL, IL, KY, LA, MD, MI, MN, MS, NC, NJ, NY, OH, OK, PA, TN, TX, and WA.. Foreign distribution to Australia.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0110-2020
- 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,
Terminated Class II Medical devices
- Recall started
- 2 December 2016
- Terminated
- 22 May 2020
- Reason
- Instruments were developed without adequate consideration given to the need for a new regulatory filing. This event was reported to FDA as part of Stryker's retrospective review of K2M product field actions; recall actions were completed in 2017.
- Distribution
- US Nationwide Distribution in the states of AL CA CO CT FL FL IL IN KS MA MI MN PA TN TX UT VA
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0052-2020
- 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 combin
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.