Z-1591-2024 Class II Ongoing
FDA device recall Z-1591-2024 was initiated by Conformis, Inc. on March 11, 2024 and is designated Class II. Reason for recall: Size 5 Tibial Tray from Lot 508287 was packaged in a Size 4 box from Lot 540287. It was confirmed that Lot 540287 and Lot 508287 were swapped between the pouching and final pack. The recall status is ongoing. Affected quantity: 3 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 24, 2024
- Initiation Date
- March 11, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 units
Product Description
Identity Imprint PS Tibial Tray Size 4: Lot 540287
Reason for Recall
Size 5 Tibial Tray from Lot 508287 was packaged in a Size 4 box from Lot 540287. It was confirmed that Lot 540287 and Lot 508287 were swapped between the pouching and final pack.
Distribution Pattern
US Nationwide distribution in the states of FL, KS and NH.
Code Information
Catalog Number: TPS-301-T04S; UDI#: M572TPS301T04S011, Lot number 540287