FDA Enforcement
Class II
Terminated
Instrument Tray, Basic T2 Femur Long Catalog #: 1806-9900 Product Usage: Knee Arthroplasty
Recall: Z-0980-2019
·
Reported March 13, 2019
Enforcement
- Recall Number
- Z-0980-2019
- Event ID
- 82140
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Stryker GmbH
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 13, 2019
- Initiation Date
- January 21, 2019
- Classification Date
- March 6, 2019
- Termination Date
- April 2, 2020
- Address
- Bohnackerweg 1, N/A, Selzach, N/A, N/A, Switzerland
Description
Instrument Tray, Basic T2 Femur Long Catalog #: 1806-9900 Product Usage: Knee Arthroplasty
Reason
The faceplates may incorrectly identify the T2 Basic Long Instrument Set as T2 Basic Short Instrument Set.
Code Info
Lot Number(s): K026ACE (lot# packaging) KU97181 (Vendor code engraved on device)
Distribution
In the countries of Canada and Korea
Quantity
17 units