PlainRecalls
FDA Devices Moderate Class II Ongoing

Identity Imprint PS Tibial Tray Size 4: Lot 540287

Reported: April 24, 2024 Initiated: March 11, 2024 #Z-1591-2024

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.

Details

Recalling Firm
Conformis, Inc.
Units Affected
3 units
Distribution
US Nationwide distribution in the states of FL, KS and NH.
Location
Billerica, MA

Frequently Asked Questions

What product was recalled?
Identity Imprint PS Tibial Tray Size 4: Lot 540287. Recalled by Conformis, Inc.. Units affected: 3 units.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on April 24, 2024. Severity: Moderate. Recall number: Z-1591-2024.