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Recall Observatory FDA recall evidence

Device product

HRIS Storage & Sterilization Case and Tray, Catalog/Part Number: 6210-9-900

Z-2152-2024

May 23, 2024

Class II

Product summary

Firm
Howmedica Osteonics Corp.
Event
Event 94708
Status
Ongoing
Classification
Class II
Quantity
630 units
Official record key
device-enforcement:Z-2152-2024

Official wording

Reason: 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.

Code information: Part 6210-9-900, UDI-DI: 07613327217902, 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.