RegWardenFDA facility compliance records
Facility

Microport Orthopedics, S.A.

15 recall(s) on record — most severe on record: Class I.

Activity by year

FDA actions on record by year2014: 1 recalls; 2015: 2 recalls; 2016: 4 recalls; 2017: 1 recalls; 2020: 2 recalls; 2022: 2 recalls; 2024: 2 recalls; 2025: 1 recalls1’142’154’161’17’18’192’20’212’22’232’241’25’26
  • Recalls (15)

Devices registered here (3)

  • Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
    Product code MBH (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3565
  • Knee Arthroplasty Implantation System
    Product code OOG (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3560
  • Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
    Product code JWH (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3560

Recalls & enforcement

20251 record
20242 records
  • Class IIOngoing2024-10-29
    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.
  • Class IIOngoing2024-05-03
    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.
20222 records
  • Class IITerminated2022-10-28
    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.
  • Class IITerminated2022-05-04
    One manufacturing lot is missing the plasma-spray coating in the proximal region of the stem body.
20202 records
  • Class IIOngoing2020-07-31
    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).
  • Class ITerminated2020-07-31
    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 represe…
20171 record
  • Class IITerminated2017-09-18
    The item is being recalled due to an inadequate pouch seal. This defect has the potential to lead to a loss of sterile pouch integrity, which could impact the products sterility assurance and may lead to serious adverse events such as infections, both localized and systemic.
20164 records
  • Class IITerminated2016-11-17
    The recall is being initiated because all broach handles in the affected lot had the same non-conformity with the connection feature. The broach handles may have machining issues that do not allow the handle to properly mate with an associated broach.
  • Class IITerminated2016-06-30
    Profemur(R) neck, Item Number PHA01222 (Short AR VV2 Ti Neck) was labeled as Item Number PHA01212 (Short AR VV1 Ti Neck).
  • Class ITerminated2016-06-21
    ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening.
  • Class IIITerminated2016-06-21
    Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modular head Metal on Metal THA systems show an increasing overall trend from 2009 to present and it was found that there was a specific hazard/harm for suspected tissue reaction to metal d…
20152 records
  • Class ITerminated2015-08-04
    Unexpected rate of postoperative fractures resulting in the need for revision surgery.
  • Class IITerminated2015-02-02
    Some units of the EVOLUTION Tibial Base was affected by a casting tool issue which caused varying retaining wall thickness and keel offset in the finished product.
20141 record

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Microport Orthopedics, S.A. (FEI 3010856250) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3010856250-microport-orthopedics-s-a/

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