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K2M, Inc Recall 87565

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

K2M, Inc Recall 87565 Information

StatusTerminated
Mandated?Voluntary: Firm initiated
Recall NumberZ-1410-2021
Event ID87565
Event DescriptionChesapeake Cervical-Ti 10mm Drill Guide Inserter- a multi-screw construct providing stability to the anterior column (cervical spine) Catalog number: 3608-90033
Product TypeDevices
DistributionPA
Quantity1 unit
Recall ReasonInterference 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
Device Classification20210421
Device Code InfoLot Number: MNAJ GTIN: 10888857082571
Center Classification Date20210412
Recall Initiation Date20210316
Recalling FirmK2M, Inc
Initial Notification Letter
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