Z-0686-2022Class II

Titanium MPJ (Toe Implant)TOE JOINT TITANIUM PC SM, Part ID 17035

Name: Z-0686-2022 Titanium MPJ (Toe Implant)TOE JOINT TITANIUM PC SM, Part ID 17035
Creator: BioPro, Inc.
Published: 2022-02-01
License: https://open.fda.gov/license/

Biopro, Inc. / initiated 2022-02-01 / Terminated / root cause: labeling and UDI

FDA source

BioPro, Inc. began a recall of Titanium MPJ (Toe Implant)TOE JOINT TITANIUM PC SM, Part ID 17035 on 2022-02-01. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0686-2022
Classification: Class II
Status: Terminated
Initiated: 2022-02-01
Posted: 2022-02-28
Terminated: 2024-02-28
Recalling firm: Biopro, Inc.
Product: Titanium MPJ (Toe Implant)TOE JOINT TITANIUM PC SM, Part ID 17035
Product code: KWD Prosthesis, Toe, Hemi-, Phalangeal
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.
Root cause tag: labeling and UDI
FDA root cause: 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.
Product codes and lots: Lot Number: 124735, 128448, 126522; UDI: 00810012480239

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0686-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0682-2022	Class II	Terminated	Voluntary: Firm initiated	2022-03-09	2022-02-28
Z-0683-2022	Class II	Terminated	Voluntary: Firm initiated	2022-03-09	2022-02-28
Z-0684-2022	Class II	Terminated	Voluntary: Firm initiated	2022-03-09	2022-02-28
Z-0685-2022	Class II	Terminated	Voluntary: Firm initiated	2022-03-09	2022-02-28
Z-0686-2022	Class II	Terminated	Voluntary: Firm initiated	2022-03-09	2022-02-28
Z-0687-2022	Class II	Terminated	Voluntary: Firm initiated	2022-03-09	2022-02-28
Z-0688-2022	Class II	Terminated	Voluntary: Firm initiated	2022-03-09	2022-02-28
Z-0689-2022	Class II	Terminated	Voluntary: Firm initiated	2022-03-09	2022-02-28
Z-0690-2022	Class II	Terminated	Voluntary: Firm initiated	2022-03-09	2022-02-28
Z-0691-2022	Class II	Terminated	Voluntary: Firm initiated	2022-03-09	2022-02-28

Product code KWD

K041595Class IIToe Mp Joint, Models 10412-10414, 14958, 14960, 1060-10062,16818,-16822,16867-16870Biopro, Inc. / cleared 2004-11-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)