Titanium Toe Joint Implant Contains False MR Compatibility Claims
BioPro recalled titanium toe implants due to incorrect claims in documentation about magnetic resonance (MR) compatibility testing that was never conducted. The FDA issued a Class II recall to address the misleading safety information.
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 FDA Class II implant recall involves incorrect labeling claiming MR safety testing that was never conducted. Although no injuries have been reported, this constitutes a risk-of-harm product (untested implants in MRI environment could cause serious injury), meeting criteria for a High severity score.
Plain-English summary
BioPro, Inc. has recalled titanium toe joint implants (Part ID 17037) due to incorrect statements in product documentation regarding magnetic resonance (MR) compatibility. The product's instructions for use and patient implant cards falsely claim that the titanium MPJ implant has been tested for safety and compatibility in the MR environment and is MR Conditional. However, MR testing has not been conducted on the titanium version of this implant.
The recalled implants have lot numbers 124737 and 125470 (UDI M20917037) and were distributed nationwide in Connecticut, Kentucky, New Mexico, Pennsylvania, Tennessee, and South Dakota. Patients with this implant should consult their healthcare provider before undergoing magnetic resonance imaging (MRI) to clarify whether their specific device has been tested for MR safety.
The recalled product
- Product
- Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC M/L, Part ID 17037
- Manufacturer
- BioPro, Inc.
- Category
- Medical Device — Toe Implants
- 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 (3)
- Lot Number: 124737
- 125470
- UDI: M20917037
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.
See all 10 products in this recall →Related recalls
Same manufacturer · BioPro, Inc.
See all →- HighCeramic endo modular heads recalled over sterile barrier packaging defect
FDA (Devices) · 2025-10-22
- HighMetal and ceramic femoral heads recalled over sterile barrier packaging defect
FDA (Devices) · 2025-10-22
- HighCeramic femoral heads recalled over packaging that may compromise sterile barrier
FDA (Devices) · 2025-10-22
- HighFemoral head implants recalled over packaging that may compromise sterile barrier
FDA (Devices) · 2025-10-22
- HighBipolar femoral heads recalled over packaging that may compromise sterility
FDA (Devices) · 2025-10-22
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- ModerateHalyard Laparoscopy Comprehensive Pack II Recalled for Latex Content
FDA (Devices) · 2026-10-14
Similar recalls
- CriticalJaw joint implants recalled over a discrepancy in screw hole position
FDA (Devices) · 2025-11-26
- ModerateIntegra Recalls Salto Talaris Ankle Prosthesis Due to Labeling Error
FDA (Devices) · 2019-04-24
- ModerateBiomet Microfixation Recalls Total Temporomandibular Joint Replacement Systems
FDA (Devices) · 2014-12-17
- ModerateBiomet Microfixation Recalls TMJ Fossa Component Due to Product Mix-Up
FDA (Devices) · 2014-09-10
- ModerateIntegra Salto Talaris Ankle Prosthesis Recalled for Incorrect Labeling
FDA (Devices) · 2019-04-24
- ModerateWright Medical Recalls Swanson Great Toe Implants Due to Sterility Documentation
FDA (Devices) · 2019-12-04