Chesapeake Cervical-Ti 10mm Drill Guide Inserter- a multi-screw construct providing stability to the anterior column (cervical spine) Catalog number: 3608-90033
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot Number: MNAJ GTIN: 10888857082571
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- K2M, Inc
- 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
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Chesapeake Cervical-Ti 10mm Drill Guide Inserter- a multi-screw construct providing stability to the anterior column (cervical spine) Catalog number: 3608-90033
Product Codes/Lot Numbers:
Lot Number: MNAJ GTIN: 10888857082571
Distribution:
Distributed in: PA
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1410-2021
Related Recalls
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Stryker received two (2) complaints for units from specific lots of Inner and Outer Dilators not fitting together properly during a surgical procedure. Some dilators from these lots and from other lots were subsequently determined to be affected by a manufacturing nonconformance.
Stryker received two (2) complaints for units from specific lots of Inner and Outer Dilators not fitting together properly during a surgical procedure. Some dilators from these lots and from other lots were subsequently determined to be affected by a manufacturing nonconformance.