CHESAPEAKE Stabilization System recallZ-1410-2021 · K2M, Inc · initiated Mar 16, 2021
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from K2M, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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
FDA root cause category: Under Investigation by firm
What the company is doing
Stryker Spine issued Urgent Medical Device Recal letter that issued on 3/16. Letter states reason for recall, health risk and action to take: Our records indicate Stryker previously distributed catalog no. 3608-90033, Lot MNAJ to your location in a Stryker Loaner Set. The nonconforming instrument was subsequently identified and quarantined during routine processing of loaner sets by Stryker at its Leesburg facility. This communication is being made for notification purposes only. The only action requested of you is to complete the Business Reply Form found on the following page and return it to the email address referenced on the form. If you have any questions or concerns, please contact Stryker Spine Regulatory Compliance at 201-749-8090. On behalf of Stryker we thank you sincerely for your help and support in completing this action by the target date March 19, 2021.
Recall details
- Recall number
- Z-1410-2021
- Status
- Terminated
- Initiated by the company
- Mar 16, 2021
- Recalling firm
- K2M, Inc
- Quantity
- 1 unit
- Product code
- HRS
- FDA submissions
- K111439
- Distribution
- PA
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
Code information (models, lots, serial numbers)
Lot Number: MNAJ GTIN: 10888857082571
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- CHESAPEAKE Stabilization System 3608-90033VB Spine LLC · Orthopedic manual surgical instrument1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page