FDAFDA · Food and drugs·Recall number Z-0083-2019
OrthoSensor VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Right, REF ZBH-PSNCREF311-R.
Published October 17, 2018 · Recall initiated: July 12, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Some sensors were reported to have fluid inside the posterior lateral corner post-surgery.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Orthosensor, Inc.
- Distributor
- Distribution was made CA, FL, IL, IN, MI, NY, and NC. Foreign distribution was made to Australia. There was no government/military distribution.
- Lot
- Lot numbers 20569, 20576, 20594, and 20618, UDI 00816818021447.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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