FDA recall Z-1410-2021

Product

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

Distribution

PA

Key facts

Status

Terminated

Initiation date

2021-03-16

Report date

2021-04-21

Termination date

2021-08-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Leesburg, VA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1410-2021