Gray Revision Instrument System Accessory Tray/Case, Catalog/Part Number: 6210-9-910
Recall
- Recall Number
- Z-2153-2024
- Event Number
- 94708
- Firm
- Howmedica Osteonics Corp.
- FEI Number
- 3003070421
- Product Code
- LXH
- Status
- Open, Classified
- Root Cause
- Device Design
- Initiated
- May 23, 2024
- Posted
- June 18, 2024
- Address
- 325 Corporate Dr, Mahwah, NJ, 07430-2006
Description
Gray Revision Instrument System Accessory Tray/Case, Catalog/Part Number: 6210-9-910
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.
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 [email protected]/ 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
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.
209 units