Titanium Toe Implant Recalled for Incorrect MR Compatibility Claims
BioPro Titanium MPJ toe implants are being recalled due to incorrect statements in device labeling claiming MR Conditional status when MR testing was not performed on the titanium version.
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: Per the severity rubric, this Class II recall qualifies as High because it is a risk-of-harm product with no reported illnesses or injuries. The misstatement about MR safety represents a theoretical hazard requiring correction but without documented adverse events.
Plain-English summary
BioPro, Inc. is recalling the Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC SM, Part ID 16813 (Lot Number 128667) due to incorrect safety statements in device labeling.
The Instructions for Use (IFU BP102303 rev 05) and patient implant cards (revision 00) incorrectly state that the Titanium MPJ implant is "MR Conditional" and has been tested for safety and compatibility in magnetic resonance (MR) environments. In reality, MR testing has not been conducted on the titanium version of the MPJ implant, meaning its safety in MR environments is unknown.
The recall affects patients and healthcare providers across the United States, with distribution confirmed in Connecticut, Kentucky, New Mexico, Pennsylvania, Tennessee, and South Dakota.
Patients with this implant who may be scheduled for MR procedures should inform their healthcare provider of the implant's untested MR status. Clinicians should obtain and review corrected labeling from BioPro and counsel patients about the limitations of MR compatibility information for this device.
The recalled product
- Product
- Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC SM, Part ID 16813
- Manufacturer
- BioPro, Inc.
- Hazard
- mislabeling
- 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: 128667
- UDI: 00810012480086
Distribution
Distributed nationwide across the United States.
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