Howmedica Osteonics Corp.: Medical Device Recall in 2024 - (Recall #: Z-2153-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

Gray Revision Instrument System Accessory Tray/Case, Catalog/Part Number: 6210-9-910

Product Classification:

Class II

Date Initiated: May 23, 2024

Date Posted: June 26, 2024

Recall Number: Z-2153-2024

Event ID: 94708

Reason for Recall:

The design of the HRIS Storage & Sterilization Case and Tray P/N 6210-9-900 and the Gray Revision Instrument System Accessory Tray/Case P/N 6210-9-910 may lead to misuse of the Gray Revision Instruments including re-use and re-sterilization of the single-use, sterile-packaged instruments.

Status: Ongoing

Product Quantity: 209 units

Code Information:

Part 6210-9-910, UDI-DI: 07613327217780, Lot#: All lots back to 2006.

Distribution Pattern:

Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Brazil, Canada, Chile, Denmark, Hong Kong, Iran, Italy, Japan, Kuwait, Mexico, New Zealand, Singapore, Spain, Sweden, Switzerland, Thailand, Turkey, UK, Venlo.

Voluntary or Mandated:

Voluntary: Firm initiated