Reported Mar 9, 2022 · Terminated
Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MS, Part ID 17197
BioPro, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: BioPro, Inc. · 2929 Lapeer Rd · Port Huron, MI · 48060-2558
Is this the product you have?
- Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MS, Part ID 17197
- Lot codes and dates
- Lot Number128361
- UDI00810012480277
This recall covers 10 products
The agency filed one notice per product. You are reading one of them; the other 9 are below.
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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