Recall Z-0980-2019
Stryker GmbH · initiated January 21, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Instrument Tray, Basic T2 Femur Long Catalog #: 1806-9900 Product Usage: Knee Arthroplasty
Codes / lots: Lot Number(s): K026ACE (lot# packaging) KU97181 (Vendor code engraved on device)
Reason for recall
The faceplates may incorrectly identify the T2 Basic Long Instrument Set as T2 Basic Short Instrument Set.
FDA-determined cause: Employee error
Action taken
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.
Details
- Recall number
- Z-0980-2019
- Initiated
- January 21, 2019
- Terminated
- April 2, 2020
- Product code
- LRO – General Surgery Tray
- Quantity
- 17 units
- Distribution
- In the countries of Canada and Korea
- Recalling firm
- Stryker GmbH, Selzach