CLASS II Device recall · Reported 9 Mar 2022 · FDA Enforcement Report

Titanium Mpj (Toe Implant) Toe Joint Titanium Npc SM, Part ID recalled

BioPro is recalling Titanium Mpj (Toe Implant) Toe Joint Titanium Npc SM, Part ID 16813, distributed nationwide in the US. The recall was initiated on 1 Feb 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Number: 128667; UDI: 00810012480086

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0682-2022
FDA event ID: 89605
Recalling firm: BioPro, Port Huron, MI
Classification: Class II
Status: Terminated
Recall initiated: 1 Feb 2022
FDA classified: 28 Feb 2022
Reported: 9 Mar 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Other Medical Devices

Timeline

1 Feb 2022	Recall initiated by company
28 Feb 2022	Classified by FDA	+27 days
9 Mar 2022	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC SM, Part ID 16813

Where it was distributed

US Nationwide distribution in the states of CT, KY, NM, PA, TN, and SD.

Nationwide Connecticut Kentucky New Mexico Pennsylvania South Dakota Tennessee

Questions about this recall

Why was it recalled?

Which lots are affected?

Lot Number: 128667; UDI: 00810012480086

Where was it sold?

US Nationwide distribution in the states of CT, KY, NM, PA, TN, and SD.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

9 other products · FDA event 89605

This product is part of a recall event; the main page for the event is Titanium Mpj (Toe Implant) Toe Joint Titanium PC M/L, Part ID recalled.

Reported	Class	Recall	Company	Reason	Where
9 Mar 2022	CLASS II	Titanium Mpj (Toe Implant) Toe Joint Titanium PC M/L, Part ID recalled	BioPro	Labeling Errors	Nationwide
9 Mar 2022	CLASS II	Titanium Mpj (Toe Implant) Toe Joint Titanium Npc MD, Part ID recalled	BioPro	Labeling Errors	Nationwide
9 Mar 2022	CLASS II	Titanium Mpj (Toe Implant)Toe Joint Titanium Npc LG, Part ID recalled	BioPro	Labeling Errors	Nationwide
9 Mar 2022	CLASS II	Titanium Mpj (Toe Implant) Toe Joint Titanium PC MS, Part ID recalled	BioPro	Labeling Errors	Nationwide
9 Mar 2022	CLASS II	Titanium Mpj (Toe Implant) Toe Joint Titanium PC LG, Part ID recalled	BioPro	Labeling Errors	Nationwide
9 Mar 2022	CLASS II	Titanium Mpj (Toe Implant)Toe Joint Titanium PC SM, Part ID recalled	BioPro	Labeling Errors	Nationwide
9 Mar 2022	CLASS II	Titanium Mpj (Toe Implant) Toe Joint Titanium Npc ML, Part ID recalled	BioPro	Labeling Errors	Nationwide
9 Mar 2022	CLASS II	Titanium Mpj (Toe Implant) Toe Joint Titanium Npc MS, Part ID recalled	BioPro	Labeling Errors	Nationwide
9 Mar 2022	CLASS II	Titanium Mpj (Toe Implant) Toe Joint Titanium PC MD, Part ID recalled	BioPro	Labeling Errors	Nationwide

More recalls from BioPro

All 37

Reported	Class	Recall	Company	Reason	Where
22 Oct 2025Device	CLASS II	Femoral Head (Ceramic heads 28-30) Product ID/Description recalled	BioPro	Sterility	MI, TX
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22 Oct 2025Device	CLASS II	Femoral Head Product ID/Description 14089 Head Femoral recalled	BioPro	Sterility	MI, TX
22 Oct 2025Device	CLASS II	Endo Head (Ceramic) Product ID/Description 13006 Endo recalled by BioPro	BioPro	Sterility	MI, TX
22 Oct 2025Device	CLASS II	Femoral Head (Metal 22, 28, 32, 36, cobalt chromium recalled by BioPro	BioPro	Sterility	MI, TX

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