Device recall: Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC SM, Part ID 16813
Class II FDA enforcement event 89605. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
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.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
BioPro, Inc. started this device recall on 1 Feb 2022. The firm address in the FDA record is in Port Huron, MI. FDA put the recall in Class II. FDA event 89605 has 10 product records. The first FDA enforcement report date is 9 Mar 2022. The record gives the status Terminated, with the termination date 28 Feb 2024.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
US Nationwide distribution in the states of CT, KY, NM, PA, TN, and SD.
Recalling firm
BioPro, Inc., Port Huron, MI.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
10 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0682-2022 | Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC SM, Part ID 16813 | Class II | Terminated | 9 Mar 2022 | |
| Z-0683-2022 | Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MD, Part ID 16814 | Class II | Terminated | 9 Mar 2022 | |
| Z-0684-2022 | Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC ML, Part ID 16815 | Class II | Terminated | 9 Mar 2022 | |
| Z-0685-2022 | Titanium MPJ (Toe Implant)TOE JOINT TITANIUM NPC LG, Part ID 16816 | Class II | Terminated | 9 Mar 2022 | |
| Z-0686-2022 | Titanium MPJ (Toe Implant)TOE JOINT TITANIUM PC SM, Part ID 17035 | Class II | Terminated | 9 Mar 2022 | |
| Z-0687-2022 | Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MD, Part ID 17036 | Class II | Terminated | 9 Mar 2022 | |
| Z-0688-2022 | Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC M/L, Part ID 17037 | Class II | Terminated | 9 Mar 2022 | |
| Z-0689-2022 | Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC LG, Part ID 17038 | Class II | Terminated | 9 Mar 2022 | |
| Z-0690-2022 | Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MS, Part ID 17197 | Class II | Terminated | 9 Mar 2022 | |
| Z-0691-2022 | Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MS, Part ID 17198 | Class II | Terminated | 9 Mar 2022 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2022
- 839
- Share of these events in Class II
- 88%
- Product records in this event
- 10Median of the firm: 10
- Events of the firm on the register
- 3
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 9 Sep 2025 | BioPro Femoral Head (Metal 22, 28, 32, 36, 40) cobalt chromium and ceramic heads Part ID/Description: 18593 HEAD FEMORAL | Device | Class II | 6 |
| 25 Jun 2019 | K-Wire HBS Sterile, Item Number 19688 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS S | Device | Class II | 21 |
Official channels
- FDA enforcement report Z-0682-2022The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 89605. https://recallregister.com/fda/ii/89605/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
US Nationwide distribution in the states of CT, KY, NM, PA, TN, and SD.
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2022 have the same class?
- 88% of the 839 device events that started in 2022 are in Class II.
- How many FDA recalls does BioPro, Inc. have?
- BioPro, Inc. is the recalling firm in 3 enforcement events on this register. This event is 1 of them.