Titanium MPJ recall
Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MD, Part ID 17036
Why was Titanium MPJ recalled?
There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the MR Environment and is MR Conditional. MR Testing has not been conducted on the titanium version of the MPJ.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Number: 127603, 125590; UDI: 00810012480246
- Product
- Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MD, Part ID 17036
- Recalling firm
- BioPro, Inc.
- Distribution
- US Nationwide distribution in the states of CT, KY, NM, PA, TN, and SD.
- Recall date
- March 9, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)