PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: April 21, 2021 Initiated: March 16, 2021 #Z-1410-2021

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

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

Details

Recalling Firm
K2M, Inc
Units Affected
1 unit
Distribution
PA
Location
Leesburg, VA

Frequently Asked Questions

What product was recalled?
Chesapeake Cervical-Ti 10mm Drill Guide Inserter- a multi-screw construct providing stability to the anterior column (cervical spine) Catalog number: 3608-90033. Recalled by K2M, Inc. Units affected: 1 unit.
Why was this product 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
Which agency issued this recall?
This recall was issued by the FDA Devices on April 21, 2021. Severity: Moderate. Recall number: Z-1410-2021.