Lower risk Medical device recall · FDA · Published February 1, 2022

BioPro Titanium Toe Implant: MR Safety Risk

BioPro recalls Titanium MPJ toe implants due to unverified MR safety claims. The implant may not be safe for MRI scans as testing was not done on the titanium version.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0688-2022Medical device BioPro ›

Lower-risk 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.

Take action

Contact the company

Recalling firmBioPro, Inc.2929 Lapeer Rd · Port Huron, MI 48060-2558

✎ GovInfoNow plain-language explainer

BioPro is recalling a specific titanium toe implant model because it hasn't been tested for MRI safety. This means patients could face risks if they undergo MRI scans without knowing the implant's compatibility. Read more at govinfonow.com/recall/61189-biopro-titanium-toe-implant-mr-safety-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/61189-biopro-titanium-toe-implant-mr-safety-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0688-2022

Cite this page

“BioPro Titanium Toe Implant: MR Safety Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61189-biopro-titanium-toe-implant-mr-safety-risk. Based on FDA recall #Z-0688-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0688-2022%22&limit=1).

BioPro, Inc. voluntarily recalled Titanium MPJ toe implants on Feb. 1, 2022, after the FDA found incorrect MR compatibility statements in the instructions for use and patient cards. The agency announced the Class II recall because MR testing had not been conducted on the titanium version.

How to tell if you have it

Brand: BioPro
Product: Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC M/L
Part ID: 17037
Lot Numbers: 124737, 125470
UDI: M20917037

The hazard

The recall addresses incorrect statements in the BioPro Titanium MPJ implant IFU (BP102303 rev 05) and patient implant cards (22266 rev 00) indicating the device is MR Conditional. The FDA noted that MR testing has not been conducted on this titanium version of the implant.

Context

GovInfoNow's records show BioPro, Inc. has two other recalls on record since June 25, 2019, including a Sept. 9, 2025 recall for packaging defects and a June 25, 2019 recall for sterile barrier flaws. Other recent recalls of similar products include I.T.S. Foot Locking Plates System (Jan. 23, 2026), I.T.S. Fibula Plate PROlock with Angular Stability (Jan. 23, 2026), and I.T.S. GmbH Pelvic Reconstruction System (Jan. 23, 2026).

How to tell if you have this one

Check for the part ID 17037 on the implant. The recall includes specific lot numbers: 124737 and 125470. This implant is used for toe joints and has a unique UDI code M20917037.

Brand
BioPro
Category
Medical device

FDA recall event · 10 products

All 10 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Terminated
Distribution
US Nationwide distribution in the states of CT, KY, NM, PA, TN, and SD.

Recall number	Product, codes & lots	Quantity
Z-0682-2022	Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC SM, Part ID 16813; Lot Number: 128667; UDI: 00810012480086	—
Z-0683-2022	Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MD, Part ID 16814; Lot Number: 125423, 128356; UDI: 00810012480093	—
Z-0684-2022	Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC ML, Part ID 16815; Lot Number: 124738, 127602; UDI: 00810012480109	—
Z-0685-2022	Titanium MPJ (Toe Implant)TOE JOINT TITANIUM NPC LG, Part ID 16816; Lot Number: 125672, 128357; UDI: 00810012480116	—
Z-0686-2022	Titanium MPJ (Toe Implant)TOE JOINT TITANIUM PC SM, Part ID 17035; Lot Number: 124735, 128448, 126522; UDI: 00810012480239	—
Z-0687-2022	Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MD, Part ID 17036; Lot Number: 127603, 125590; UDI: 00810012480246	—
Z-0688-2022	Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC M/L, Part ID 17037; Lot Number: 124737, 125470; UDI: M20917037	—
Z-0689-2022	Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC LG, Part ID 17038; Lot Number: 124926; UDI: M209 17038	—
Z-0690-2022	Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MS, Part ID 17197; Lot Number: 128361; UDI: 00810012480277	—
Z-0691-2022	Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MS, Part ID 17198; Lot Number: 125651; UDI: M20917198	—

Based on the official FDA remedy

What to do — step by step

Check Implant Details
Look for the part ID 17037 and lot numbers 124737 or 125470 on the implant.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 6 states.

FDA distribution: “US Nationwide distribution in the states of CT, KY, NM, PA, TN, and SD.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Connecticut, Kentucky, New Mexico, Pennsylvania, South Dakota, Tennessee.

Recall timeline

FDA terminated this recall 2.1 years after the firm started it.

Feb 1, 2022Firm started the recall
Feb 28, 2022FDA classified it Class II
Mar 9, 2022Published in FDA’s Enforcement Report
Feb 28, 2024FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/61189-biopro-titanium-toe-implant-mr-safety-risk">BioPro Titanium Toe Implant: MR Safety Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0688-2022 (February 1, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0688-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.