FDA Medical Device Recalls (openFDA)
Howmedica Osteonics Corp.: Gray Revision Instrument System Accessory Tray/Case, Catalog/Part Number: 6210-9-910
- Recall number
- Z-2153-2024
- Recalling firm
- Howmedica Osteonics Corp.
- Product
- Gray Revision Instrument System Accessory Tray/Case, Catalog/Part Number: 6210-9-910
- Status
- Open, Classified
- Initiated
- 2024-05-23
- Posted
- 2024-06-18
- Terminated
- not on file
- 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.
- Root cause
- Device Design
- Action
- On May 23, 2024 MEDICAL DEVICE RECALL letters were sent to customers. Actions needed: Our records indicate that you may have received the affected product(s). It is Stryker s responsibility as the manufacturer to ensure that customers who may have received these affected products also receive this important communication. We therefore request that you read this notice carefully and complete the following actions. 1. Please inform users of this Medical Device Recall and forward this notice to all individuals who need to be made aware. 2. Immediately check all stock areas and/or operating room storage at your facility to determine if any Gray Revision Instruments from the affected product list in Table 2 have been removed from sterile packaging (Gray Revision Instruments are single-use, sterile-packaged manual surgical instruments). 3. If any Gray Revision Instruments have been removed from sterile packaging, discard/dispose of those instruments. 4. Gray Revision Instruments found within their sterile packaging may be used as intended (single-use, sterile-packaged). 5. Do not use the HRIS Storage & Sterilization Case and Tray or the Gray Revision Instrument System Accessory Tray/Case to re-process (re-sterilize, clean, or re-use) the Gray Revision Instruments, which are single-use, sterile-packaged manual surgical instruments. 6. You may continue to use the HRIS Storage & Sterilization Case and Tray or the Gray Revision Instrument System Accessory Tray/Case for all other instruments as intended. 7. Complete and sign the enclosed Medical Device Recall Business Reply Form and email to strykerortho7963@sedgwick.com/ fax (844) 412-9273. 8. Please contact your Local Sales Office or your Stryker Sales Representative directly for product replacement and inventory questions. Please assist us in meeting our regulatory obligation by emailing back the attached Medical Device Recall Business Reply Form within 5 days. A response is required, even though you may not have any physic
- Quantity
- 209 units
- Distribution
- 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.
- Lot, serial or model codes
- Part 6210-9-910, UDI-DI: 07613327217780, Lot#: All lots back to 2006.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LXH
- Firm FEI
- 3003070421
- Firm city
- Mahwah
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28