FDA-Device2024-04-24Class II
Identity Imprint PS Tibial Tray Size 4: Lot 540287
Conformis, Inc.
Hazard
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.
Sold states
US Nationwide distribution in the states of FL, KS and NH.
Affected count
3 units
Manufactured in
600 Technology Park Dr # 400, Billerica, MA, United States
Products
Identity Imprint PS Tibial Tray Size 4: Lot 540287
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1591-2024Don't want to check this manually?
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