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U.S. Department of Health and Human Services

Class 2 Device Recall BioPro MPJ

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  Class 2 Device Recall BioPro MPJ see related information
Date Initiated by Firm February 01, 2022
Create Date February 28, 2022
Recall Status1 Terminated 3 on February 28, 2024
Recall Number Z-0691-2022
Recall Event ID 89605
510(K)Number K041595  
Product Classification Prosthesis, toe, hemi-, phalangeal - Product Code KWD
Product Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MS, Part ID 17198
Code Information Lot Number: 125651; UDI: M20917198
Recalling Firm/
Manufacturer		 BioPro, Inc.
2929 Lapeer Rd
Port Huron MI 48060-2558
For Additional Information Contact Patrick Pringle
810-982-7777
Manufacturer 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 2		 Labeling design
Action 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
Distribution US Nationwide distribution in the states of CT, KY, NM, PA, TN, and SD.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KWD and Original Applicant = BIOPRO, INC.
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