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.
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
Take action
Contact the company
📍Recalling firmK2M, Inc600 Hope Pkwy SE · Leesburg, VA 20175-4428
“K2M Chesapeake Cervical-Ti 10mm Drill Guide Inserter Recall: Spinal Injury Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63062-k2m-chesapeake-cervical-ti-10mm-drill-guide-inserter-recall-spinal. Based on FDA recall #Z-1410-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1410-2021%22&limit=1).
The FDA announced on March 16, 2021, that K2M, Inc. voluntarily recalled the Chesapeake Cervical-Ti 10mm Drill Guide Inserter due to an interference condition that may cause spinal cord injury or screw malposition. The recall affects units distributed in Pennsylvania.
How to tell if you have it
K2M
Chesapeake Cervical-Ti 10mm Drill Guide Inserter
Catalog number: 3608-90033
Lot Number: MNAJ
UPC: 10888857082571
The hazard
The recall cites an interference condition between the 10mm Drill Guide Inserter and the inner shaft, causing the shafts to not mate flush with collet inserters and resulting in splaying of the collet. This defect may cause implants to fall into the spinal cord, potentially causing a spinal cord injury, or result in misalignment of screws with the inserter screw guide, potentially causing malposition of the screws into adjacent vertebral bodies.
Context
GovInfoNow's records show K2M, Inc. has had 10 other recalls on record since July 24, 2018. Other recent recalls include the K2M Yukon Straight Rod 4.0x120mm Recall (June 13, 2022), the K2M Everest MI XT Outer Dilator Recall (Jan. 13, 2022), and the K2M Chesapeake AL Removal Tool Recall (Sept. 8, 2021).
How to tell if you have this one
Check for catalog number 3608-90033 and lot number MNAJ on the device. This product is used in cervical spine surgeries and sold with specific identifiers.
Brand
K2M
Product
K2M, Inc recalls Chesapeake Cervical-Ti 10mm Drill Guide Inserter- a multi-screw construct providing stability to the anterior column
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Identification
Look for catalog number 3608-90033 and lot number MNAJ on the Chesapeake Cervical-Ti 10mm Drill Guide Inserter.
Where it went and when
Where it was distributed
Distributed in Pennsylvania.
Listed by the agency
Not listed
FDA distribution: “PA” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Pennsylvania.
Recall timeline
FDA terminated this recall 5 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-1410-2021 (March 16, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1410-2021 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.