Recall Z-0980-2019 ยท LRO General Surgery Tray
Stryker GmbH
Instrument Tray, Basic T2 Femur Long Catalog #: 1806-9900 Product Usage: Knee Arthroplasty
| Date | Jan 21, 2019 |
| Status | Terminated |
| Reason | The faceplates may incorrectly identify the T2 Basic Long Instrument Set as T2 Basic Short Instrument Set. |
| Root cause | Employee error |
| Action | Zimmer Biomet issued Urgent Field Safety Notice PFA 1982723 customer letter dated: January 21, 2019. Letter identifies affected product, problem and action to be taken: Inform individuals within your organization who need to be aware of this action. 2. Immediately check all stock areas and/or operating room storage to determine if any devices from the affected product list are at your facility. Response is required, even you may not have any physical inventory on site anymore. 3. Quarantine and discontinue use of the devices. |
| Quantity | 17 units |
| Distribution | In the countries of Canada and Korea |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.