Arlington, TN, United States
MicroPort Orthopedics Inc. recalls
7 recalls recorded since 2018, most recently on 19 December 2025. 4 are listed as ongoing. Status and classification are as published by the FDA.
Recalls7
Ongoing (FDA)4
Terminated or completed3
Class I (FDA)1
Ongoing Class II Medical devices
- Recall started
- 19 December 2025
- Reason
- Due to products not having FDA Premarket authorization to be distributed within the United States.
- Distribution
- The product was sent to distributors in multiple US states, including Texas, California, Wisconsin, Kansas, Illinois, Michigan, Tennessee, Maryland, Washington, Georgia, Colorado, Missouri, and Florida. The product was also sent to the following countries: Belgium, Germany, France, Italy, United Ki
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1133-2026
- Brand Name: MicroPort Product Name: HIPTURN FEM HEAD TRIAL 36MM REUSABLE Model/Catalog Number: HTHT0036 Software Version: N/A Product Description: HIPTURN FEM HEAD TRIAL 36MM REUSABLE
Ongoing Class II Medical devices
- Recall started
- 29 October 2024
- Reason
- Femoral implant porous size 5 right primary and femoral implant non-porous size 6 left primary have correct markings on devices, but may have incorrect packaging.
- Distribution
- OUS: CN, GR, ES, ZA, FR, JP, IT
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0699-2025
- EVOLUTION MP FEMORAL COMPONENT CS/CR POROUS SIZE 5 RIGHT PRIMARY, REF: EFSRP5PR; EVOLUTION MP FEMORAL COMPONENT CS/CR NON-POROUS SIZE 6 LEFT PRIMARY, REF: EFSRN6PL Knee prosthesis component
Ongoing Class II Medical devices
- Recall started
- 3 May 2024
- Reason
- One confirmed incident has been received that EFSRN4PR, lot number MP1982170, Size 4 Evolution MP Non-Porous Femoral Right was opened during surgery and contained part number EFSRN3PL, lot number MP1982097, Size 3 Evolution MP Non-Porous Femoral Left in the packaging.
- Distribution
- International distribution in the country of China. There is no field inventory in the United States for either lot.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2244-2024
- EVOLUTION¿ MP Femoral CS/CR Non-Porous Non-porous MicroPort total knee replacement implants are for cemented use only.
Terminated Class II Medical devices
- Recall started
- 28 October 2022
- Terminated
- 10 September 2026
- Reason
- One confirmed incident has been received that ETPKN2PL lot 1916559, size 2 Evolution MP Tibial Base, was opened during surgery and contained ETPKN7SL lot 1916715, size 7 Evolution MP Tibial Base, in the packaging.
- Distribution
- International Distribution to countries of: Germany, Italy, France, Belgium, Austria, Greece, Romania, Japan, and P.R. China.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0276-2023, Z-0275-2023
- EVOLUTION MP Tibial Bases, Size 7 LEFT, REF ETPKN7SL, knee tibial base
- EVOLUTION MP Tibial Bases, Size 2+ LEFT, REF ETPKN2PL, knee tibial base
Terminated Class II Medical devices
- Recall started
- 4 May 2022
- Terminated
- 16 January 2024
- Reason
- One manufacturing lot is missing the plasma-spray coating in the proximal region of the stem body.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of FL, IN, MO, CA and the country of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1225-2022
- PROFEMUR PLASMA Z CLASSIC STEM SIZE 7 STANDARD SHORT NECK
Ongoing Class II Medical devices
- Recall started
- 31 July 2020
- Reason
- MicroPort Orthopedics Inc. is voluntarily recalling any existing inventory of PROFEMUR¿ Titanium and Cobalt Chrome modular necks with previous package insert versions to replace the PROFEMUR¿ Hip System Package Insert with the most recent revision (150803-8).
- Distribution
- Worldwide Distribution: US (nationwide) to states of: AL, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, MA, MD, MI, MO, MT, NC, NH, NJ, NV, OH, PA, TN, TX, UT, VA, WA, WI including PR; and countries of: Brazil, Canada, China, Costa Rica, France, Germany, Japan, The Netherlands and United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2948-2020
- PROFEMUR Titanium and Cobalt Chrome modular necks, Item Numbers and descriptions: Item Number Description Description 2 PHAC1202 PROFEMUR NECK NEUTRAL SHORT COBALT CHROME PHAC1204 PROFEMUR NECK NEUTRAL LONG COBALT CHR
Terminated Class I Medical devices
- Recall started
- 31 July 2020
- Terminated
- 16 April 2024
- Reason
- MicroPort Orthopedics Inc. states that there have been reports of fractures of the long and extra-long Titanium modular femoral neck component after implantation. Worldwide there were 680 Long and X-Long PROFEMUR Titanium modular neck fractures among 123,840 global sales representing is a cumulative rate of modular neck device fracture of 0.55% from 2002 to 2019. Within the United States there were 349 Long and X-Long PROFEMUR¿ Titanium modular neck fractures among 15,786 United States sales representing a cumulative rate of modular neck device fracture with a fracture rate in the United States of 2.21% from 2002 to 2019. There is an average time of 5.4 years to device fracture after implantation.
- Distribution
- worldwide, except China and Japan
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2941-2020, Z-2942-2020
- PROFEMUR Neck Long Titanium, Catalog Numbers: PHA01204, PHA01214, PHA01224, PHA01234, PHA01244, PHA01254, PHA01264. Hip prosthesis component.
- PROFEMUR Neck Extra Long Titanium, Catalog Numbers: PHA01206, PHA01236, PHA01256. Hip prosthesis component
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.