| Class 2 Device Recall Stryker Gray Revision Instrument System Accessory Tray/Case |  |
Date Initiated by Firm | May 23, 2024 |
Date Posted | June 18, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-2153-2024 |
Recall Event ID |
94708 |
Product Classification |
Orthopedic manual surgical instrument - Product Code LXH
|
Product | Gray Revision Instrument System Accessory Tray/Case, Catalog/Part Number: 6210-9-910 |
Code Information |
Part 6210-9-910, UDI-DI: 07613327217780, Lot#: All lots back to 2006. |
Recalling Firm/ Manufacturer |
Howmedica Osteonics Corp. 325 Corporate Dr Mahwah NJ 07430-2006
|
For Additional Information Contact | Loriann Russo 201-831-5000 |
Manufacturer 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. |
FDA Determined Cause 2 | 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 in Commerce | 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. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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