FDA recall Z-1591-2024

Product

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

US Nationwide distribution in the states of FL, KS and NH.

Key facts

Status

Ongoing

Initiation date

2024-03-11

Report date

2024-04-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Billerica, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1591-2024