Summary
The FDA issued a Class II for Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC SM, Part ID 16813 by BioPro, Inc.. Reason: There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (222.
Details
Source
Device Recall
External ID
Z-0682-2022
Action Date
2022-03-09
Status
Terminated
Category
device
Product Description
Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC SM, Part ID 16813
Lot/Code Info: Lot Number: 128667; UDI: 00810012480086
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.
Distribution
US Nationwide distribution in the states of CT, KY, NM, PA, TN, and SD.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-02-01
Company
Port Huron, MI
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 130 device recalls issued in the same week, part of 403 device-related FDA actions this month.
BioPro, Inc. has 16 FDA actions in our database, including 16 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (BioPro, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does BioPro, Inc. have FDA actions?
BioPro, Inc. has 16 FDA actions in our database, including 16 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0682-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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