BioPro Titanium Toe Implant Recalled for Incorrect MRI Safety Claims
BioPro Titanium MPJ toe implants contain incorrect documentation falsely claiming they are MR Conditional without proper testing. Patients should not assume these implants are safe for 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 Class II device recall involving incorrect safety labeling about MRI compatibility on an orthopedic implant. No illnesses or injuries have been reported. The recall addresses a risk-of-harm scenario where patients could be exposed to potential MRI-related complications if they rely on the false claims, but this is mitigated by communication of corrected information.
Plain-English summary
BioPro, Inc. is recalling the Titanium MPJ toe implant (Part ID 16816, Lot Numbers 125672 and 128357) due to incorrect statements in the product's Instructions for Use (IFU BP102303 rev 05) and patient implant cards (22266 rev 00).
The documentation falsely states that the BioPro Titanium MPJ implant has been tested for safety and compatibility in MR (magnetic resonance/MRI) environments and is MR Conditional. However, MR testing has not been conducted on the titanium version of this implant, making these claims inaccurate and misleading about its true MRI safety status.
This recall affects patients who received these implants distributed in Connecticut, Kentucky, New Mexico, Pennsylvania, Tennessee, and South Dakota. Patients with this implant should inform their healthcare providers and should not assume the implant is safe for MRI without explicit confirmation from BioPro or their surgeon.
Patients with a Titanium MPJ implant from BioPro should verify their lot number and contact their healthcare provider or BioPro, Inc. directly to obtain corrected information regarding MRI safety before undergoing any MRI procedures.
The recalled product
- Product
- Titanium MPJ (Toe Implant)TOE JOINT TITANIUM NPC LG, Part ID 16816
- Manufacturer
- BioPro, Inc.
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: 125672
- 128357
- UDI: 00810012480116
Distribution
Part of a larger recall action
This product is one of 10 recalled by BioPro, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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