Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC M/L, Part ID 17037
Reported: March 9, 2022 Initiated: February 1, 2022 #Z-0688-2022
Product Description
Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC M/L, Part ID 17037
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.
Details
- Recalling Firm
- BioPro, Inc.
- Distribution
- US Nationwide distribution in the states of CT, KY, NM, PA, TN, and SD.
- Location
- Port Huron, MI
Frequently Asked Questions
What product was recalled? ▼
Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC M/L, Part ID 17037. Recalled by BioPro, Inc..
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on March 9, 2022. Severity: Moderate. Recall number: Z-0688-2022.
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