Titanium Toe Implants Recalled for Incorrect MRI Safety Labeling
BioPro Titanium MPJ toe implants are recalled because labeling incorrectly claims MRI safety without actual testing. Patients should consult their physician before undergoing MRI procedures.
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 risk-of-harm scenario where patients could be exposed to untested MRI procedures if they rely on the incorrect labeling. Although no injuries or illnesses have been reported, the potential for serious harm exists if patients with this implant undergo MRI without proper medical consultation.
Plain-English summary
BioPro, Inc. is recalling Titanium MPJ (Toe Implant) devices, Part ID 17035, due to an incorrect statement in the Instructions for Use (IFU BP102303 rev 05) and patient implant cards (22266 rev 00). These documents incorrectly indicate that the titanium version has been tested for safety and compatibility in the MRI environment and is MR Conditional. In fact, MR Testing has not been conducted on the titanium version of the MPJ.
The affected implants were distributed nationwide in Connecticut, Kentucky, New Mexico, Pennsylvania, Tennessee, and South Dakota. Lot numbers affected include 124735, 128448, and 126522. The device UDI is 00810012480239.
Patients with this implant should not undergo MRI procedures without first consulting their physician regarding the untested status of this device. Contact BioPro, Inc. for corrected labeling. Any patient who has undergone an MRI with this implant should seek medical evaluation to assess for any potential complications.
The recalled product
- Product
- Titanium MPJ (Toe Implant)TOE JOINT TITANIUM PC SM, Part ID 17035
- Manufacturer
- BioPro, Inc.
- Hazard
- mis-labeling
- untested-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 (4)
- Lot Number: 124735
- 128448
- 126522
- UDI: 00810012480239
Distribution
Distributed nationwide across the United States.
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