Recall Z-0685-2022— BioPro, Inc.

Name: FDA recall Z-0685-2022
Creator: U.S. Food and Drug Administration
Published: 2022-02-01

Class II · Terminated

Class II FDA medical device recall by BioPro, Inc., initiated 2022-02-01, terminated 2024-02-28. It names one FDA 510(k) clearance: K041595. Product: Titanium MPJ (Toe Implant)TOE JOINT TITANIUM NPC LG, Part ID 16816. Reason: 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.
Classification: Class II
Status: Terminated
Initiated: 2022-02-01
Terminated: 2024-02-28
Firm location: Port Huron, MI, United States

510(k) clearances named in this recall

1 on FDA's record

K041595 — TOE MP JOINT, MODELS 10412-10414, 14958, 14960, 1060-10062,16818,-16822,16867-16870Biopro, Inc.·cleared 2004-11-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Titanium MPJ (Toe Implant)TOE JOINT TITANIUM NPC LG, Part ID 16816

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.