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Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC SM, Part ID 16813

FDA Recall #Z-0682-2022 — Class II — February 1, 2022

Recall #Z-0682-2022 Date: February 1, 2022 Classification: Class II Status: Terminated

Product Description

Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC SM, Part ID 16813

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.

Recalling Firm

BioPro, Inc. — Port Huron, MI

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Distribution

US Nationwide distribution in the states of CT, KY, NM, PA, TN, and SD.

Code Information

Lot Number: 128667; UDI: 00810012480086

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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