Go Backs
HomeCategoriesStatesCheck Your Home
Go Backs

Track product recalls and safety alerts from CPSC, FDA, NHTSA, and USDA. Stay informed and keep your family safe.

Browse

  • Categories
  • States
  • Check Your Home
  • Risk Levels

Agencies

  • CPSC
  • FDA Food
  • FDA Drug
  • FDA Device
  • FDA Veterinary
  • NHTSA
  • USDA

Company

  • About
  • FAQ
  • Contact
  • Terms of Service
  • Privacy Policy
Buy Me a Coffee

Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

ยฉ 2026 Go Backs. All rights reserved.

Medium RiskFDA Device
Medical Devices/Surgical Equipment

Howmedica Osteonics Corp.: HRIS and Gray Revision Instrument Trays Recalled for Sterilization Risk

Agency Publication Date: June 18, 2024
Share:
Sign in to monitor this recall

Summary

Howmedica Osteonics Corp. is recalling approximately 839 HRIS Storage & Sterilization Cases and Gray Revision Instrument System Accessory Trays. These trays are designed to hold surgical instruments, but the current design may mistakenly lead healthcare staff to re-use and re-sterilize instruments that are intended for single-use only and come sterile-packaged. This recall includes all lots of these specific storage systems distributed since 2006. Consumers and healthcare facilities should contact the manufacturer regarding the next steps for these storage systems.

Risk

The design of the storage cases may cause single-use surgical instruments to be placed back into the tray for re-sterilization, which could lead to surgical delays or the use of improperly sterilized equipment on patients.

What You Should Do

  1. Identify if you have the HRIS Storage & Sterilization Case and Tray (Part Number 6210-9-900) or the Gray Revision Instrument System Accessory Tray/Case (Part Number 6210-9-910).
  2. Check the labeling for UDI-DI 07613327217902 (for part 6210-9-900) or UDI-DI 07613327217780 (for part 6210-9-910), including all lots manufactured from 2006 to the present.
  3. Review your inventory and sterilization protocols to ensure that single-use, sterile-packaged Gray Revision instruments are not being placed in these trays for re-processing.
  4. Contact Howmedica Osteonics Corp. (Stryker) at their Mahwah, New Jersey facility or through your local representative for further instructions regarding the tray design issue.
  5. Contact your healthcare provider if you have concerns regarding a procedure involving these instrument trays.
  6. For additional information, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer Instruction and Corrective Action

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: HRIS Storage & Sterilization Case and Tray
Model / REF:
6210-9-900
UPC Codes:
07613327217902
Lot Numbers:
All lots back to 2006
Date Ranges: Distributed since 2006
Product: Gray Revision Instrument System Accessory Tray/Case
Model / REF:
6210-9-910
UPC Codes:
07613327217780
Lot Numbers:
All lots back to 2006
Date Ranges: Distributed since 2006

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94708
Status: Active
Manufacturer: Howmedica Osteonics Corp.
Sold By: Hospital supply chains; Medical device distributors
Manufactured In: United States
Units Affected: 2 products (630 units; 209 units)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.