Use cautionMedical device recall · FDA · Published September 8, 2021
K2M Chesapeake AL Removal Tool Recall: Missing Pins Risk Surgery 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.
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.
Take action
Contact the company
📍Recalling firmK2M, Inc600 Hope Pkwy SE · Leesburg, VA 20175-4428
“K2M Chesapeake AL Removal Tool Recall: Missing Pins Risk Surgery Complications.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61821-k2m-chesapeake-al-removal-tool-recall-missing-pins-risk-surgery. Based on FDA recall #Z-0104-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0104-2022%22&limit=1).
K2M, Inc. recalled the Chesapeake Anterior Lumbar (AL) Removal Tool on Sept. 8, 2021, according to the FDA. The device may arrive with missing pins or in a disassembled state. This Class II recall involves 23 units distributed domestically and internationally.
Units may arrive with missing pins and/or in a state of disassembly. Pins dislodging from the instrument during a procedure may enter the surgical cavity, requiring intraoperative removal or revision surgery.
Context
GovInfoNow's records show K2M, Inc. has had 10 other recalls since July 24, 2018. Other recent recalls of similar products include Charlotte Claw Screw Recall (Aug. 18, 2026), SeaSpine Mariner Deformity Product Recall (Aug. 19, 2026), and Intuitive Surgical Da Vinci Surgical System Recall (April 22, 2026).
How to tell if you have this one
Check for model number 2008-90068 and lots CCUNA, HYMJ, or KNCU. The tool is sold under K2M, Inc. as the Chesapeake Anterior Lumbar Removal Tool.
Brand
K2M
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Tool Condition
Inspect the tool for missing pins before use. If pins are missing, do not use the tool.
Where it went and when
Where it was distributed
Distributed in 9 states, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “Domestic distribution to CO, IL, LA, MA, MS, OK, PA, TN, and TX. Foreign distribution to Columbia, UK, Netherlands, and Canada.” States read from FDA’s own wording; “not listed” means the notice does not name it.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0104-2022 (September 8, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0104-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.