Z-0980-2019 Class II Terminated
FDA device recall Z-0980-2019 was initiated by Stryker GmbH on January 21, 2019 and is designated Class II. Reason for recall: The faceplates may incorrectly identify the T2 Basic Long Instrument Set as T2 Basic Short Instrument Set. The recall status is terminated (terminated April 2, 2020). Affected quantity: 17 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 13, 2019
- Initiation Date
- January 21, 2019
- Termination Date
- April 2, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 17 units
Product Description
Instrument Tray, Basic T2 Femur Long Catalog #: 1806-9900 Product Usage: Knee Arthroplasty
Reason for Recall
The faceplates may incorrectly identify the T2 Basic Long Instrument Set as T2 Basic Short Instrument Set.
Distribution Pattern
In the countries of Canada and Korea
Code Information
Lot Number(s): K026ACE (lot# packaging) KU97181 (Vendor code engraved on device)