Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Chesapeake Cervical-Ti 10mm Drill Guide Inserter- a multi-screw construct providing Recalled by K2M, Inc Due to Interference condition between the 10mm Drill Guide Inserter...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact K2M, Inc directly.
Affected Products
Chesapeake Cervical-Ti 10mm Drill Guide Inserter- a multi-screw construct providing stability to the anterior column (cervical spine) Catalog number: 3608-90033
Quantity: 1 unit
Why Was This Recalled?
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
Where Was This Sold?
This product was distributed to 1 state: PA
About K2M, Inc
K2M, Inc has 38 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report