Home / Recalls / MicroPort Orthopedics Inc. / Z-2942-2020

Z-2942-2020 Class I Terminated

Recalled by MicroPort Orthopedics Inc. — Arlington, TN

Recall Details

Product Type
Devices
Report Date
September 30, 2020
Initiation Date
July 31, 2020
Termination Date
April 16, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
556 units

Product Description

PROFEMUR Neck Extra Long Titanium, Catalog Numbers: PHA01206, PHA01236, PHA01256. Hip prosthesis component

Reason for Recall

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 Pattern

worldwide, except China and Japan

Code Information

All lots/serial numbers

Other recalls by MicroPort Orthopedics Inc.

  • Z-1133-2026 Class II — Brand Name: MicroPort Product Name: HIPTURN FEM HEAD TRIAL 36MM REUSABLE Model (December 19, 2025)
  • Z-0699-2025 Class II — EVOLUTION MP FEMORAL COMPONENT CS/CR POROUS SIZE 5 RIGHT PRIMARY, REF: EFSRP5PR; (October 29, 2024)
  • Z-2244-2024 Class II — EVOLUTION¿ MP Femoral CS/CR Non-Porous Non-porous MicroPort total knee replac (May 3, 2024)
  • Z-0276-2023 Class II — EVOLUTION MP Tibial Bases, Size 7 LEFT, REF ETPKN7SL, knee tibial base (October 28, 2022)
  • Z-0275-2023 Class II — EVOLUTION MP Tibial Bases, Size 2+ LEFT, REF ETPKN2PL, knee tibial base (October 28, 2022)
  • Z-1225-2022 Class II — PROFEMUR PLASMA Z CLASSIC STEM SIZE 7 STANDARD SHORT NECK (May 4, 2022)
  • Z-2941-2020 Class I — PROFEMUR Neck Long Titanium, Catalog Numbers: PHA01204, PHA01214, PHA01224, PHA (July 31, 2020)
  • Z-2948-2020 Class II — PROFEMUR Titanium and Cobalt Chrome modular necks, Item Numbers and descriptions (July 31, 2020)
  • Z-0043-2018 Class II — MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R (September 18, 2017)
  • Z-0943-2017 Class II — PROFEMUR(R) R RASP HANDLE, REF PPW38078, 1 EACH, NON-STERILE, MicroPort Orthoped (November 17, 2016)