BioPro Titanium MPJ Toe Implant MRI Safety Labeling Error
BioPro is recalling Titanium MPJ toe implants due to false MRI safety labeling. The instructions and patient cards incorrectly state the device was tested for MRI safety, but no testing was conducted.
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: FDA Class II labeling error with risk-of-harm potential. The false claim that the titanium implant is MR Conditional could lead patients to undergo MRI procedures with an untested device, creating safety concerns even though no injuries have been reported.
Plain-English summary
BioPro, Inc. is recalling Titanium MPJ (Toe Joint Titanium) implants with Part ID 16815. These devices were distributed nationwide to Connecticut, Kentucky, New Mexico, Pennsylvania, Tennessee, and South Dakota. Affected lot numbers are 124738 and 127602.
The implant's instructions for use (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) contain an incorrect statement claiming the device has been tested for safety and compatibility in the MR (magnetic resonance/MRI) environment and is MR Conditional. However, MR testing has not been conducted on the titanium version of this implant.
Patients who rely on this false labeling may undergo MRI procedures believing their implant is safe when its actual MR safety status is unknown. If an untested implant is exposed to MRI, device heating, malfunction, or other complications may occur.
Patients with affected implants should contact their surgeon or healthcare provider before any planned MRI procedures to clarify the true MRI safety status. Healthcare providers should notify affected patients and verify MRI safety protocols.
The recalled product
- Product
- Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC ML, Part ID 16815
- 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: 124738
- 127602
- UDI: 00810012480109
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.
See all 10 products in this recall →Related recalls
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