Chesapeake Cervical-Ti 10mm Drill Guide Inserter- a multi-screw construct providing stability to the anterior column (cervical spine) Catalog number: 3608-90033
Check against the official notice below — it lists the full affected range.
K2M, Inc. is recalling the Chesapeake Cervical-Ti 10mm Drill Guide Inserter (Catalog number 3608-90033), a device used to provide stability to the anterior cervical spine during multi-screw surgical constructs. The recall affects one unit distributed in Pennsylvania (Lot Number: MNAJ). The device has an interference condition between the 10mm Drill Guide Inserter and its inner shaft, preventing them from mating flush together and causing splaying of the collet.
This manufacturing defect creates potential risks during spinal surgery. If the implant falls into the spinal cord, it could cause spinal cord injury. Additionally, if the inserter does not seat completely on the implant, the screws may become misaligned with the inserter screw guide, potentially resulting in screws being positioned incorrectly into adjacent vertebral bodies. The source document does not specify what actions affected consumers should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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
Reason for recall: 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 Quantity: 1 unit Lot/code info: Lot Number: MNAJ GTIN: 10888857082571
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.