BioPro, Inc. 2022-03-09 Health serious FDA
Health · FDA · Recall #FDA-Z-0688-2022
Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC M/L, Part ID 17037 Recall
Issued March 9, 2022 · BioPro, Inc.
In March 2022, BioPro, Inc. recalled the Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC M/L, Part ID 17037, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC M/L, Part ID 17037 right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact BioPro, Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- BioPro, Inc.
- Category
- Health
- Recall date
- March 9, 2022
- Units affected
- Not reported
- Sold at
- US Nationwide distribution in the states of CT, KY, NM, PA, TN, and SD.
- Recall number
- FDA-Z-0688-2022
- Made in
- United States
- Issuing agency
- FDA
In context
- BioPro, Inc. has 2 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 870th Health recall we've logged in 2022.