BioPro Titanium MPJ Toe Implant Recalled for Incorrect MR Compatibility Labeling
BioPro is recalling Titanium MPJ toe implants because instructions and patient cards falsely claim the devices are compatible with MRI imaging, when safety testing for this titanium version has not been conducted.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II medical device recall involving a labeling error in product instructions and patient information cards. No illnesses or injuries have been reported. The false claim about MR compatibility creates a precautionary concern, but the error is primarily a documentation issue rather than an inherent product defect, supporting a Moderate severity rating.
Plain-English summary
BioPro, Inc. is recalling the Titanium MPJ toe joint implant (Part ID 16814) due to incorrect information in the product instructions and patient implant cards.
The Instructions for Use (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) contain statements indicating that the BioPro MPJ Titanium implant has been tested for safety and compatibility in magnetic resonance (MR) environments and is MR-safe. However, MR testing has not been conducted on the titanium version of the MPJ implant. This false claim could lead patients to undergo MR imaging procedures under the mistaken belief that their implant is MR-safe, which has not been verified.
The recalled implants were distributed nationwide in the following states: Connecticut, Kentucky, New Mexico, Pennsylvania, Tennessee, and South Dakota. The affected lot numbers are 125423 and 128356, with UDI 00810012480093.
Patients with the Titanium MPJ implant should contact their healthcare provider before undergoing any MR imaging procedures. BioPro is updating the instructions and patient cards to correct the MR compatibility claims. Healthcare providers should inform their patients of this correction and verify MR safety with BioPro or appropriate testing before allowing any MR procedures.
The recalled product
- Product
- Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MD, Part ID 16814
- 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 (3)
- Lot Number: 125423
- 128356
- UDI: 00810012480093
Distribution
Distributed nationwide across the United States.
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