Identity Imprint PS Tibial Tray Size 4: Lot 540287
Class I - DangerousWhat Should You Do?
- Check if you have this product: Catalog Number: TPS-301-T04S; UDI#: M572TPS301T04S011, Lot number 540287
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Conformis, Inc.
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Identity Imprint PS Tibial Tray Size 4: Lot 540287
Product Codes/Lot Numbers:
Catalog Number: TPS-301-T04S; UDI#: M572TPS301T04S011, Lot number 540287
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1591-2024
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Loctite thread locker (epoxy) may not have been applied to the screw that is part of the handle. In the absence of epoxy, the screw may loosen and fall into the patient during a procedure.