The Recall Desk
HighFDA (Devices)·Z-0689-2022·Announced 2022-03-09

Titanium Toe Joint Implant Labeling Error: Unvalidated MRI Safety Claims

BioPro Titanium MPJ toe implants are recalled due to false documentation claiming MRI safety testing that was never performed. Patients should not undergo MRI with this implant until properly evaluated.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This FDA Class II recall involves a risk-of-harm medical device with incorrect safety labeling. Although no injuries or illnesses have been reported, patients may undergo MRI imaging based on false safety claims, which could cause device complications. Per the severity rubric, risk-of-harm products where injury has not been reported qualify as High severity.

Plain-English summary

BioPro, Inc. is recalling the Titanium MPJ (Toe Implant) with Part ID 17038 due to incorrect statements in the product documentation and patient implant cards. The materials claim the implant has been tested for safety and compatibility in the MR (magnetic resonance/MRI) environment and is "MR Conditional," but MR testing has not actually been conducted on the titanium version.

Medical implants that have not been validated for MRI use may heat up, move, or malfunction when exposed to an MRI machine. Patients who believe their implant is MRI-safe based on the incorrect labeling may undergo MRI imaging when they should not, creating a potential safety risk.

This recall affects Titanium MPJ implants with Lot Number 124926 (UDI: M209 17038) distributed nationwide in Connecticut, Kentucky, New Mexico, Pennsylvania, Tennessee, and South Dakota.

If you have received this implant, inform your healthcare provider of this recall. Do not undergo MRI procedures until your implanting physician or BioPro can confirm the device's actual MRI safety status.

The recalled product

Product
Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC LG, Part ID 17038
Manufacturer
BioPro, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
  • mis-labeling
  • mri-safety

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot Number: 124926
  • UDI: M209 17038

Distribution

Distributed nationwide across the United States.

Related recalls

Same category