CLASS II Device recall · Reported 9 Mar 2022 · FDA Enforcement Report
Titanium Mpj (Toe Implant) Toe Joint Titanium Npc MS, Part ID recalled
BioPro is recalling Titanium Mpj (Toe Implant) Toe Joint Titanium Npc MS, Part ID 17198, 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
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-0691-2022
- 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 MS, Part ID 17198
Where it was distributed
US Nationwide distribution in the states of CT, KY, NM, PA, TN, and SD.
Nationwide ConnecticutKentuckyNew MexicoPennsylvaniaSouth DakotaTennessee
Questions about this recall
Is Titanium Mpj (Toe Implant) Toe Joint Titanium Npc MS, Part ID 17198 recalled?
Yes. BioPro recalled Titanium Mpj (Toe Implant) Toe Joint Titanium Npc MS, Part ID 17198 on 1 Feb 2022. The recall is Class II and its status is Terminated. Recall number Z-0691-2022.
Why was it recalled?
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.
Which lots are affected?
Lot Number: 125651; UDI: M20917198
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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