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.
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 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
- 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: 124737
- 125470
- UDI: M20917037
Distribution
Distributed nationwide across the United States.
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