Chesapeake Cervical-Ti 10mm Drill Guide Inserter- a recall
Chesapeake Cervical-Ti 10mm Drill Guide Inserter- a multi-screw construct providing stability to the anterior column (cervical spine) Catalog number…
Why was Chesapeake Cervical-Ti 10mm Drill Guide Inserter- a 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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Number: MNAJ GTIN: 10888857082571
- Product
- Chesapeake Cervical-Ti 10mm Drill Guide Inserter- a multi-screw construct providing stability to the anterior column (cervical spine) Catalog number…
- Recalling firm
- K2M, Inc
- Quantity
- 1 unit
- Distribution
- PA
- Recall date
- April 21, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)