FDAFDA · Food and drugs·Recall number Z-1591-2024
Identity Imprint PS Tibial Tray Size 4: Lot 540287
Published April 24, 2024 · Recall initiated: March 11, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Conformis, Inc.
- Distributor
- US Nationwide distribution in the states of FL, KS and NH.
- Lot
- Catalog Number: TPS-301-T04S; UDI#: M572TPS301T04S011, Lot number 540287
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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