Titanium Toe Implant Recalled for Incorrect MRI Safety Claims
BioPro Titanium MPJ toe implant documentation incorrectly claims MRI safety testing that was never conducted. The implant is not proven safe for MRI use.
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 an FDA Class II recall involving incorrect labeling of MRI safety claims on a medical implant. No illnesses or injuries have been reported. The hazard is theoretical—false documentation that could lead to patient harm if not corrected—meeting the criteria for High severity (risk-of-harm products where injury has not yet been reported).
Plain-English summary
BioPro, Inc. is recalling the Titanium MPJ (Toe Implant), Part ID 17036, due to incorrect safety information in the product instructions and patient cards.
The implant's instructional materials (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) incorrectly state that the implant has been tested for safety and compatibility in magnetic resonance imaging (MRI) environments and is MR Conditional. MRI testing has not been conducted on the titanium version of this implant.
The recall affects implants distributed nationwide in Connecticut, Kentucky, New Mexico, Pennsylvania, Tennessee, and South Dakota (Lot Numbers 127603 and 125590; UDI 00810012480246). Patients with this implant should inform their healthcare providers of this recall and discuss MRI safety before undergoing any MRI procedures.
The recalled product
- Product
- Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MD, Part ID 17036
- Manufacturer
- BioPro, Inc.
- Hazard
- incorrect-labeling
- mri-incompatibility
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: 127603
- 125590
- UDI: 00810012480246
Distribution
Distributed nationwide across the United States.
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