K2M Chesapeake Cervical Drill Guide Inserter Recalled for Interference Defect
K2M, Inc. is recalling the Chesapeake Cervical-Ti 10mm Drill Guide Inserter due to an interference condition that may cause spinal cord injury or screw misalignment.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of significant injury, specifically spinal cord injury or malposition of screws into vertebral bodies, which meets the criteria for a Severe rating.
Plain-English summary
K2M, Inc. is recalling the Chesapeake Cervical-Ti 10mm Drill Guide Inserter, a multi-screw construct used to provide stability to the anterior column of the cervical spine. The recall involves 1 unit with Lot Number MNAJ and GTIN 10888857082571, distributed in Pennsylvania.
The recall is due to an interference condition between the 10mm Drill Guide Inserter and the inner shaft that mates with the inserters. This defect results in inner shafts not mating flush with the collet inserters and causes splaying of the collet. If the implant falls into the spinal cord, it may cause a spinal cord injury. Additionally, 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.
Healthcare providers and patients who have used or are using this specific device should contact K2M, Inc. for further instructions on how to proceed.
The recalled product
- Product
- Chesapeake Cervical-Ti 10mm Drill Guide Inserter- a multi-screw construct providing stability to the anterior column (cervical spine) Catalog number: 3608-90033
- Manufacturer
- K2M, Inc
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Number: MNAJ GTIN: 10888857082571
Distribution
Distributed in 1 state:
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