Titanium Toe Implant Recalled for Incorrect MRI Safety Statements
BioPro is recalling Titanium MPJ toe implants due to false claims of MRI compatibility. The device instruction manual states it is MRI-safe despite not being tested.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 is an FDA Class II recall involving a false safety statement about MRI compatibility. No illnesses, injuries, or deaths have been reported. The hazard is theoretical—the potential risk from incorrect MRI safety information—but no actual harm has been documented. Per the rubric, risk-of-harm products without reported injury score at most High (3).
Plain-English summary
BioPro, Inc. is recalling the Titanium MPJ (toe implant), Part ID 17197, due to an incorrect statement in the product documentation regarding MRI compatibility. The instruction manual (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) indicate that the Titanium MPJ implant has been tested for safety and compatibility in the MR environment and is MR Conditional. However, MRI testing has not been conducted on the titanium version of the implant.
The recalled devices were distributed nationwide in Connecticut, Kentucky, New Mexico, Pennsylvania, Tennessee, and South Dakota (Lot Number 128361; UDI 00810012480277). The inaccurate statement could lead patients and healthcare providers to make decisions about MRI imaging based on incorrect information about the device's safety profile.
The recalled product
- Product
- Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MS, Part ID 17197
- Manufacturer
- BioPro, Inc.
- Hazard
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: 128361
- UDI: 00810012480277
Distribution
Part of a larger recall action
This product is one of 10 recalled by BioPro, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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