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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Gray Revision Instrument System Accessory Tray/Case

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 Class 2 Device Recall Stryker Gray Revision Instrument System Accessory Tray/Casesee related information
Date Initiated by FirmMay 23, 2024
Date PostedJune 18, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2153-2024
Recall Event ID 94708
Product Classification Orthopedic manual surgical instrument - Product Code LXH
ProductGray 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 ContactLoriann 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
ActionOn 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 Commerce209 units
DistributionWorldwide 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 CycleTPLC Device Report

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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