Recall Z-2153-2024 ยท LXH Orthopedic Manual Surgical Instrument
Howmedica Osteonics Corp.
Gray Revision Instrument System Accessory Tray/Case, Catalog/Part Number: 6210-9-910
| Date | Jun 18, 2024 (initiated May 23, 2024) |
| Status | Open, Classified |
| 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 s |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.