Recall Register

Food, drugs, devices › MicroPort Orthopedics Inc.

Device recall: ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA10, SIZE 1 STD; SURFACE POROUS, HA COATED; F

FDA enforcement event 74785 · Class I · initiated 21 Jun 2016 · status Terminated · terminated 26 Jul 2017

DeviceVoluntary: Firm initiated11 product recordsArlington, TN

MicroPort Orthopedics Inc. (Arlington, TN) initiated this device recall on 21 Jun 2016; FDA lists 11 product records under event 74785, classified Class I.

FDA defines Class I as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. 3% of the 1,232 device enforcement events initiated in 2016 carry the same class.

Status: Terminated, terminated 26 Jul 2017. Initiation: voluntary: firm initiated. MicroPort Orthopedics Inc. has 15 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

MicroPort Orthopedics Inc., Arlington, TN.

Reason for recall

"ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening."

Distribution

"Worldwide Distribution only to Australia, Austria, France, Italy, Spain, and United Kingdom"

Product records

Recall numberProductQuantityClassStatusReport date
Z-2693-2016ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA10, SIZE 1 STD; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 1 FEMUR & SIZE 1 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total Knee Systems are indicated for use in knee…34 unitsClass ITerminated14 Sep 2016
Z-2694-2016ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA11, SIZE 1+; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 1 FEMUR & SIZE 1 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total Knee Systems are indicated for use in knee…36 unitsClass ITerminated14 Sep 2016
Z-2695-2016ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA20, SIZE 2 STD; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 2 FEMUR & SIZE 2 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total Knee Systems are indicated for use in knee…110 unitsClass ITerminated14 Sep 2016
Z-2696-2016ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA21, SIZE 2+; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 2 FEMUR & SIZE 2 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total Knee Systems are indicated for use in knee…98 unitsClass ITerminated14 Sep 2016
Z-2697-2016ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA30, SIZE 3 STD; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 3 FEMUR & SIZE 3 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total Knee Systems are indicated for use in knee…169 unitsClass ITerminated14 Sep 2016
Z-2698-2016ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA31, SIZE 3+; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 3 FEMUR & SIZE 3 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY,MicroPort Knee Systems Total Knee Systems MicroPort Total Knee Systems are indicated for use in knee…86 unitsClass ITerminated14 Sep 2016
Z-2699-2016ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA40, SIZE 4 STD; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 4 FEMUR & SIZE 4 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total Knee Systems are indicated for use in knee…134 unitsClass ITerminated14 Sep 2016
Z-2700-2016ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA41, SIZE 4+; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 4 FEMUR & SIZE 4 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total Knee Systems are indicated for use in knee…77 unitsClass ITerminated14 Sep 2016
Z-2701-2016ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA50, SIZE 5 STD; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 5 FEMUR & SIZE 5 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total Knee Systems are indicated for use in knee…60 unitsClass ITerminated14 Sep 2016
Z-2702-2016ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA51, SIZE 5+; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 5 FEMUR & SIZE 5 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total Knee Systems are indicated for use in knee…47 unitsClass ITerminated14 Sep 2016
Z-2703-2016ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA60, SIZE 6 STD; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 6 FEMUR & SIZE 6 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total Knee Systems are indicated for use in knee…38 unitsClass ITerminated14 Sep 2016

Context

3%of 2016 device events are Class I1,232 events that year
11product records in this eventfirm median: 1
15events on this register for the firm

Other enforcement events for MicroPort Orthopedics Inc.

InitiatedProduct (first record)TypeClassRecords
19 Dec 2025Brand Name: MicroPort Product Name: HIPTURN FEM HEAD TRIAL 36MM REUSABLE Model/Catalog Number: HTHT0036 Software VersionDeviceClass II1
29 Oct 2024EVOLUTION MP FEMORAL COMPONENT CS/CR POROUS SIZE 5 RIGHT PRIMARY, REF: EFSRP5PR; EVOLUTION MP FEMORAL COMPONENT CS/CR NODeviceClass II1
3 May 2024EVOLUTION¿ MP Femoral CS/CR Non-Porous Non-porous MicroPort total knee replacement implants are for cemented use only.DeviceClass II1
28 Oct 2022EVOLUTION MP Tibial Bases, Size 2+ LEFT, REF ETPKN2PL, knee tibial baseDeviceClass II2
4 May 2022PROFEMUR PLASMA Z CLASSIC STEM SIZE 7 STANDARD SHORT NECKDeviceClass II1
31 Jul 2020PROFEMUR Neck Long Titanium, Catalog Numbers: PHA01204, PHA01214, PHA01224, PHA01234, PHA01244, PHA01254, PHA01264. Hip DeviceClass I2
31 Jul 2020PROFEMUR Titanium and Cobalt Chrome modular necks, Item Numbers and descriptions: Item Number Description Description 2 DeviceClass II1
18 Sep 2017MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R Product Usage: MPO Total Hip Systems arDeviceClass II1
17 Nov 2016PROFEMUR(R) R RASP HANDLE, REF PPW38078, 1 EACH, NON-STERILE, MicroPort Orthopedics, Arlington, TN Instruments support tDeviceClass II1
30 Jun 2016PROFEMUR(R) MODULAR NECK, HIP FEMORAL NECK MicroPort total hip systems intended for use in total hip arthroplasty for reDeviceClass II1

All 15 events for MicroPort Orthopedics Inc.

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening."

What does Class I mean?

FDA classifies recalls by relative degree of health hazard. Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

Where was the product distributed?

FDA's distribution pattern field reads: "Worldwide Distribution only to Australia, Austria, France, Italy, Spain, and United Kingdom"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 26 Jul 2017. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.