Recall Z-0682-2022

Reason for recall

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.

FDA-determined cause: Labeling design

Action taken

An URGENT: MEDICAL DEVICE RECALL notification letter was distributed to customers on 2/1/22. Actions to be taken by the Customer BioPro has fully reviewed all records pertaining to the product and implant cards. To date, no implant cards have been issued for titanium MPJ implants. However, your facility has implanted one MPJ Implant whose IFU improperly contained the MR Conditional Statement. The information pertaining to that order is below. Please take the following actions 1. If the incorrect IFU was retained, replace it with the updated IFU, which has been included for your reference. Please dispose of the incorrect IFU. 2. Provide the enclosed corrected patient implant card to your patient who received the implant. 3. Please sign and return the following page acknowledging receipt of this notification. Actions Taken by the Recalling Firm All impacted labeling has been updated by BioPro. We apologize for any inconvenience or issue this may cause. Please feel free to contact BioPro directly if you have any questions. Hours of operation are Monday Friday from 8:00-5:00 PM est. If you are aware of any issues that may have occurred related to this implant, please notify BioPro, Inc immediately. You may additionally contact the FDA directly via the MedWatch Adverse Event Reporting program. Submit reports to the FDA through the MedWatch program in one of the following ways: " Complete the MedWatch Online Reporting Form (https://www.accessdata.fda.gov/scripts/medwatch/) " Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178