Titanium MPJ Toe Implant Recalled for Incorrect MR Safety Labeling
BioPro is recalling Titanium MPJ toe implants (Lot 125651) with inaccurate labeling claiming MR compatibility when the implant has not been tested for magnetic resonance safety. Patients should consult their physician before MRI.
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 is a high-risk medical implant product with a significant labeling error regarding MR safety that could result in patient harm if patients undergo MRI without proper physician consultation. No illnesses or injuries have been reported, making the hazard theoretical. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High.
Plain-English summary
BioPro, Inc. is recalling the Titanium MPJ (Toe Implant), a medical implant designed as a replacement for the toe joint. The affected lot is 125651, with UDI M20917198.
The recall is due to incorrect information in the Instructions For Use (IFU BP102303 rev 05) and patient implant cards (22266 rev 00). These materials incorrectly state that the BioPro Titanium MPJ implant has been tested for safety and compatibility in magnetic resonance (MR) environments and is MR Conditional. No MR testing has actually been conducted on the titanium version of the MPJ. Patients relying on this inaccurate information may undergo MRI procedures without knowing that the implant's safety in an MR environment has not been established.
The recalled implants were distributed nationwide to Connecticut, Kentucky, New Mexico, Pennsylvania, Tennessee, and South Dakota. Patients who have received this implant should consult their physician regarding the labeling discrepancy and to confirm the implant's MR safety status before undergoing any magnetic resonance imaging procedures.
The recalled product
- Product
- Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MS, Part ID 17198
- Manufacturer
- BioPro, Inc.
- 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: 125651
- UDI: M20917198
Distribution
Distributed nationwide across the United States.
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