Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MD, Part ID 16814
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0683-2022.
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.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0683-2022.
Recall terminated by FDA.
✅ What you should do
- Stop using the product if you own it.
- Check the model number, lot code, or sell-by date against the recall notice above.
- Contact Biopro, Inc. or the retailer where you bought it for a refund, replacement, or repair.
- For the most current official instructions, visit the FDA recall page.
- If you've been hurt by this product, report the incident to FDA.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0683-2022.
BioPro, Inc.
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Biopro, Inc. Recall FAQ
Biopro, Inc. is the subject of a medical implants safety report: Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MD, Part ID 16814. The notice was published on February 1, 2022 by the U.S. Food and Drug Administration (FDA). Approximately 0 units are potentially affected.