K2M, Inc: Medical Device Recall in 2021 - (Recall #: Z-1410-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Chesapeake Cervical-Ti 10mm Drill Guide Inserter- a multi-screw construct providing stability to the anterior column (cervical spine) Catalog number: 3608-90033

Product Classification:

Class II

Date Initiated: March 16, 2021

Date Posted: April 21, 2021

Recall Number: Z-1410-2021

Event ID: 87565

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

Status: Terminated

Product Quantity: 1 unit

Code Information:

Lot Number: MNAJ GTIN: 10888857082571

Distribution Pattern:

Voluntary or Mandated:

Voluntary: Firm initiated