Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0688-2022 — Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC M/L, Part ID 17037

U.S. FDA — Device Enforcement · United States · 2022-02-01 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0688-2022
Date of alert
2022-02-01
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
BioPro, Inc.
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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