FDAFDA · Food and drugs·Recall number Z-0688-2022
Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC M/L, Part ID 17037
Published March 9, 2022 · Recall initiated: February 1, 2022
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
There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the MR Environment and is MR Conditional. MR Testing has not been conducted on the titanium version of the MPJ.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- BioPro, Inc.
- Distributor
- US Nationwide distribution in the states of CT, KY, NM, PA, TN, and SD.
- Lot
- Lot Number: 124737, 125470; UDI: M20917037
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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